[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atrial-fibrillation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atrial-fibrillation":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,332,0,25,[9,43,69,103,131,157,181,216,239,263,283,304,326,349,373,399,421,442,462,490,513,540,560,578,604],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100054199","a-study-of-varipulse-catheter-and-trupulse-generator-with-varipulse-pro-software-in-participants-with-paf-or-psaf-100054199",false,"NCT07429214","A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF","Workflow Study of the VARIPULSE™ Catheter With the TRUPULSE™ Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF) or Persistent Atrial Fibrillation (PsAF) With the New VARIPULSE™ Pro Software","VP-CONFIRM","Inclusion criteria:\n\n* Diagnosed with symptomatic persistent atrial fibrillation (PsAF) or paroxysmal atrial fibrillation (PAF)\n* Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) only or PVI only with cavotricuspid isthmus (CTI) dependent atrial flutter ablation\n* Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD\n* Age 18-75 years\n* Willing and capable of providing consent\n* Able and willing to comply with all pre-, post- and follow-up testing and requirements\n\nExclusion criteria:\n\n* Continuous AF greater than (\\>) 12 months (1-Year) (Longstanding Persistent AF)\n* Previous surgical or catheter ablation for atrial fibrillation\n* Any cardiac surgery within the past 2 months (60 days prior to consent date) (includes percutaneous coronary intervention \\[PCI\\])\n* Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (for example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure\n* Any carotid stenting or endarterectomy\n* Presence of left atrium (LA) thrombus\n* Severe dilatation of the LA (left atrial diameter \\[LAD\\] \\>50 millimeters \\[mm\\] antero-posterior diameter in case of transthoracic echocardiography \\[TTE\\])\n* Severely compromised left ventricular ejection fraction (LVEF less than \\[\\\u003C\\] 40 percent \\[%\\])\n* Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study\n* Prior diagnosis of pulmonary vein stenosis\n* Pre-existing hemi diaphragmatic paralysis\n* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)\n* Myocardial infarction (MI) within the past 2 months (60 days prior to consent date)\n* Documented thromboembolic event (including transient ischemic attack \\[TIA\\]) within the past 6 months \\[180 days prior to consent date\\])\n* Rheumatic Heart Disease\n* Uncontrolled heart failure or New York heart association (NYHA) function class III or IV\n* Severe mitral regurgitation\n* Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months\n* Unstable angina pectoris within the past 6 months prior to consent date\n* Acute illness or active systemic infection or sepsis\n* Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity \\[Body Mass Index \\>40 kilogram per meter square {kg\u002Fm\\^2}\\], renal insufficiency (with an estimated creatinine clearance \\\u003C 30 milliliters per minute {mL\u002Fmin}\u002F1.73 m\\^2)\n* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch, prosthetic valve or other abnormality that precludes catheter introduction or manipulation\n* Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter\n* Presence of any other condition that precludes appropriate vascular access (such as inferior vena cava \\[IVC\\] filter)\n* Significant pulmonary disease, (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease \\[COPD\\]) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms\n* Significant congenital anomaly or medical problems that in the opinion of the investigator would preclude enrollment in this study\n* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation\n* Current enrollment in an investigational study evaluating another device, biologic, or drug\n* Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU)\n* Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being\n* Life expectancy less than 12 months\n* Contraindication for MRI such as use of contrast agents due to advanced renal disease, claustrophobia, implantable pacemakers, implantable cardioverter\u002Fdefibrillators (ICDs),etc. (at principal investigator \\[PI\\] discretion)\n* Presence of iron-containing metal fragments in the body\n* Unresolved pre-existing neurological deficit","ALL","18 Years","75 Years",{"count":22,"type":23},50,"ESTIMATED","INTERVENTIONAL",[26],"NA","The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with the new VARIPULSE™ Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days up to 1year and doesn't stop on its own).",[29],"Atrial Fibrillation","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2026-03-23",{"date":38,"type":23},"2026-12-30",{"name":40,"class":41},"Biosense Webster, Inc.","INDUSTRY",10,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100053589","predicting-development-of-scaf-in-device-patients-100053589","NCT02808260","Predicting Development of SCAF in Device Patients","Predicting Development of Sub-Clinical Atrial Fibrillation in Device Patients","Inclusion Criteria:\n\n• Dual chamber permanent pacemaker or defibrillator implanted within previous 10 years\n\nExclusion Criteria:\n\n* Clinical atrial fibrillation documented by surface ECG (12 lead ECG, Telemetry, Holter)\n* Participants considered by the investigator to be unsuitable for the study for the following reason: life expectancy less than 2 years due to concomitant disease\n* Participants who are pregnant or breast-feeding\n* Congenital heart disease\n* Inherited arrhythmia syndrome, i.e. Brugada, long QT interval",{"count":51,"type":23},500,"OBSERVATIONAL","Atrial fibrillation (AF) often starts with short episodes of rapid irregular heartbeats that are only detected by implanted pacemakers or defibrillators. Usually people don't know that they have these episodes. Over time, these episodes can happen more often and last for longer periods. In some people, the heart eventually remains permanently in a fast irregular rhythm, known as atrial fibrillation. This condition can lead to strokes and blood clots. If physicians could detect atrial fibrillation at a very early stage they could treat people early and possibly prevent the condition from becoming permanent. People with implanted devices allow a unique opportunity to constantly monitor the heart rhythm so investigators can detect any irregularities immediately.\n\nInvestigators don't know which people are at risk of developing short episodes of fast irregular heartbeats that can lead to atrial fibrillation. The purpose of this study is to find out if there are proteins or chemical changes in the blood that can predict the risk of developing atrial fibrillation. These chemical changes, also known as biomarkers, may also be able to give investigators other clues about atrial fibrillation.",[29],[56,57,58],"sub-clinical atrial fibrillation","biomarkers","implanted pacemaker or defibrillator","2026-07-09",{"date":33,"type":34},{"date":62,"type":34},"2022-09-01",{"date":64,"type":23},"2034-09",{"name":66,"class":67},"Ottawa Heart Institute Research Corporation","OTHER",1,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":99,"leadSponsor":101,"locationsCount":68},"100053768","atrial-cardiomyopathy-in-patients-with-cardiovascular-kidney-metabolic-syndrome-non-invasive-characterization-100053768","NCT07697469","Atrial Cardiomyopathy in Patients With Cardiovascular-Kidney-Metabolic Syndrome: Non-invasive Characterization","Atrial Cardiomyopathy in Patients With Cardiovascular-Kidney-Metabolic Syndrome: Non-invasive Characterization (ATRIO-CKM)","ATRIO-CKM","Inclusion Criteria:\n\n* Adults aged 18 years or older presenting for cardiovascular evaluation Signed written informed consent Agreement with all protocol requirements\n\nExclusion Criteria:\n\n* Missing key data for ACM or CKM classification Hemodynamically significant valvular heart disease (greater than moderate severity) Mechanical or biological valve prostheses Temporary or permanent cardiac pacing Psychiatric pathology Thyroid pathology (active or untreated) Known cardiomyopathies (hypertrophic, dilated, restrictive, or infiltrative) Refusal to participate or inability to comply with protocol requirements",{"count":78,"type":23},200,"Cardiovascular-kidney-metabolic (CKM) syndrome is a systemic disorder characterized by pathophysiological interactions among metabolic risk factors, chronic kidney disease, and the cardiovascular system, leading to multiorgan dysfunction and increased risk of atrial fibrillation, stroke, and heart failure. Atrial cardiomyopathy (ACM) - defined as any structural, contractile, or electrical abnormality of the atria - is an increasingly recognized contributor to cardiovascular morbidity and mortality in this population. Despite growing interest in both conditions, their interplay remains poorly understood, limiting effective preventive strategies and risk-stratification approaches for this high-risk group.\n\nCKM staging offers a practical framework for anticipating ACM onset and progression. Because adiposity-driven inflammation, insulin resistance, hypertension, and early kidney injury act as upstream drivers in CKM, the left atrium becomes an early indicator of hemodynamic load and fibrosis - often preceding sustained atrial fibrillation. Early non-invasive detection of ACM across CKM stages could shift care from treating complications to modifying the underlying substrate.\n\nThis prospective observational single-center cohort study aims to phenotype ACM non-invasively across all CKM stages at first diagnosis, using standard 12-lead ECG, advanced transthoracic echocardiography with speckle-tracking, a mechanistically selected biomarker panel (NT-proBNP, MR-proANP, Fetuin-A, FGF23), and cardiac MRI.\n\nAdults aged 18 years or older presenting for cardiovascular evaluation are enrolled and grouped as CKM with ACM (study group) versus CKM without ACM (control group). All participants undergo a single standardized baseline evaluation including clinical examination, 12-lead ECG with Bayés interatrial block grading, comprehensive laboratory panel, and advanced echocardiography including left atrial global longitudinal strain by speckle-tracking.\n\nPrimary objective: characterize the relationship between ACM and CKM syndrome stages using non-invasive parameters at first diagnosis. Secondary objectives include assessment of clinical, biological, ECG, and imaging profiles of ACM in CKM; evaluation of left atrial function across CKM stages; examination of Bayés interatrial block correlations and the impact of SGLT2 inhibitors and GLP-1 receptor agonists on left atrial remodeling in HFpEF; and identification of independent ACM risk factors incorporating the full biomarker panel.\n\nStatistical analyses include multivariable logistic regression, biomarker ROC analyses, and penalized regression for derivation of a pragmatic ACM risk score with internal validation. Expected outputs include prevalence estimates, effect sizes for ACM and CKM joint categories, biomarker performance metrics, and a clinic-ready checklist for risk-stratified prevention in outpatient settings.",[81,82,29,83,84],"Cardiovascular-Kidney-Metabolic Syndrome","Atrial Cardiomyopathy","Chronic Kidney Disease","Metabolic Syndrome",[86,87,88,89,90,91,92,93,94,29,83],"atrial cardiomyopathy","CKM syndrome","on-invasive evaluation","atrial remodeling","Bayés interatrial block","speckle tracking","Fetuin-A","MR-proANP","FGF23","NOT_YET_RECRUITING","2026-07-05",{"date":33,"type":34},{"date":31,"type":23},{"date":100,"type":23},"2028-04",{"name":102,"class":67},"Grigore T. Popa University of Medicine and Pharmacy",{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":24,"phases":113,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100449718","qol-improvement-after-cardioversion-of-persistent-af-qol-cafrct-100449718","NCT05136131","QOL Improvement After Cardioversion of Persistent AF (QOL-CAFRCT)","Quality of Life Improvement After Cardioversion of Persistent AF - A Randomized Sham-Controlled Clinical Trial","QOL-CAFRCT","Inclusion Criteria:\n\n* Patients age ≥ 18 years\n* Persistent atrial fibrillation\n* Unknown symptom burden related to AF\n\nExclusion Criteria:\n\n* Known left-atrial appendage thrombus\n* Prior catheter or surgical ablation for AF\n* Intolerance or contraindication to Amiodarone\n* Contraindication to appropriate anticoagulation\n* Patient is included in another randomized clinical trial\n* Patient is unable or unwilling to provide informed consent\n* Patient with a history of noncompliance with medical therapy\n* Patient does not meet all of the above listed inclusion criteria\n* Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrolment)\n* Breastfeeding\n* Patients for whom the investigator believes that the trial is not in the interest of the patient",{"count":112,"type":23},100,[26],"Atrial fibrillation (AF) is a type of irregular heart rhythm due to electrical signal disturbances of the heart. It is a very common arrhythmia and the risk of developing AF increases with age and with other risk factors such as diabetes, high blood pressure, and underlying heart disease. The main complications of AF are heart failure and stroke. However, studies have shown that restoration of normal rhythm does not reduce these complications. Rather, these complications are mitigated by controlling the heart rate and using blood thinners to prevent stroke. Symptoms secondary to AF can occur due to the irregular heart rate and poor contraction in the atria, the top chambers of the heart. These symptoms include shortness of breath, fatigue, reduced exercise tolerance, and palpitations. Restoring sinus rhythm can sometimes alleviate these symptoms. Given that studies to date have not shown a difference in hard clinical endpoints between rate and rhythm control strategies, the decision to proceed with rhythm control depends on the patient symptom burden.\n\nRhythm control strategies in patients with persistent AF include cardioversion back to sinus rhythm with long-term recurrence prevention via anti-arrhythmic drugs (AADs) or catheter ablation. However, many studies of these procedures omit a sham placebo control arm. No atrial fibrillation procedural intervention has been compared to a sham procedure. The cardioversion procedure can easily be compared to a \"sham\" alternative, as it is non-invasive with an expected response within days-to-weeks. Thus, a cardioversion versus \"sham\" cardioversion trial will allow us to truly assess the impact of a rhythm-control strategy on QOL. It is hypothesized that cardioversion of atrial fibrillation leads to significant improvement in quality of life (QOL) compared to sham cardioversion.\n\nUnderstanding the true QOL impact of sinus rhythm restoration in patients with persistent AF is of significant importance in guiding strategies for the management of AF. Hence, by evaluating what the true effect of cardioversion on QOL in this blinded study, we can better understand the role of medical management and AF ablation in our patients and assess resource allocation to these procedures.",[29],[117,118,119,120,121],"Quality of life improvement","Electrical cardioversion","Sham cardioversion","Rhythm control","Placebo","2026-06-30",{"date":124,"type":34},"2026-07-01",{"date":126,"type":34},"2023-02-10",{"date":128,"type":23},"2027-05",{"name":66,"class":67},2,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":24,"phases":139,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":42},"100540311","stroke-alarm-efficacy-trial-100540311","NCT06315192","Stroke Alarm Efficacy Trial","StrokeAlarmEFF","INCLUSION CRITERIA\n\n1. Age 50 years or older\n2. Modified Rankin scale of 0-2.\n3. Diagnosed with either:\n\n   A. Recent\\* transient ischemic attack (TIA, G45.9), AND:\n   * ABCD2 score of ≥6, OR:\n   * Atrial fibrillation OR:\n   * Large artery atherosclerosis\\*\\*.\n\n   B. Recent\\* acute ischemic stroke (I63), AND:\n\n   • Atrial fibrillation, OR:\n   * Large artery atherosclerosis\\*\\*. C. Atrial fibrillation\u002Fflutter (I48), AND\n   * None, or reduced dose of, oral anticoagulation medication\\*\\*\\*, AND\n   * CHA2DS2-VASC score ≥4.\n\n   D. Recent\\* intracerebral hemorrhage (I61.9), AND:\n\n   • Atrial fibrillation.\n4. The patient has received the required information about the study and agrees in writing to participate.\n5. Smartphone user since at least 1 year.\n\n   * Within the last 2 weeks \\*\\*Atherosclerosis in carotid, vertebral aortic arch or major intracerebral arteries according to CTA or ultrasound.\n\n     * Including all oral anticoagulation medication such as Warfarin and NOACs. Patients with reduced dose of a NOAC can be included, regardless if this is within the approved label, or if reduced dose is chosen off-label for other reasons. Treatment with antiplatelet medication is permissible.\n\nEXCLUSION CRITERIA\n\n1. Previous inclusion in this study.\n2. Arm motor deficit from any previous medical condition.\n3. Unable to give informed consent to participate in the study.\n4. Does not master any of the languages available within the Stroke Alarm smartphone app in speech and writing.\n5. Does not have access to a Stroke Alarm compatible smartphone.\n6. Deemed unable to handle the Stroke Alarm smartphone app, or participate in planned follow-up within the framework of the study due to other diseases or circumstances.\n7. Does not want to participate.",{"count":51,"type":23},[26],"The aim of this study is to test the efficacy of the CE-marked wearable system Stroke Alarm to identify the onset of a stroke with unilateral arm motor deficit within 3 hours of onset.\n\nThis is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population.\n\nA total of 500 patients will be included in the trial. An interim analysis will determine if the stroke onset frequency is sufficient to determine the main outcome. Should the number of stroke events differ from what is expected at interim analysis, study enrollment will continue to increase cohort size.\n\nPatients who meet the criteria for participation will, after signing consent, be included and receive the Stroke Alarm bracelets that are used for 3 months. Study data will be collected as baseline at inclusion, at follow-up 3 months after inclusion and by using national Swedish registry data after completion of the study.\n\nPatients with elevated stroke risk according assessed by presence of specific criteria associated with elevated risk caused by:\n\n1. recent TIA with an ABCD2 score of ≥6, large artery atherosclerosis or atrial fibrillation, OR\n2. recent ischemic stroke with large artery atherosclerosis or atrial fibrillation, without persisting arm motor deficit, OR\n3. atrial fibrillation with an CHA2DS2-Vasc score ≥ 4 without adequate anticoagulation OR\n4. recent hemorrhagic stroke with atrial fibrillation, without persisting arm motor deficit The combined efficacy goal is at least 60% sensitivity for Stroke Alarm b of stroke with unilateral arm motor deficit within 3 hours of onset (with a 95% confidence interval above 30%) and a specificity of at least 80% using a clinical stroke diagnosis as gold standard.\n\nA control population matched for calendar year, age (± 5 years), sex, healthcare region, baseline stroke severity according to the National Institutes of Health Stroke Scale (NIHSS, ± 5 points), unilateral arm motor deficit (NIHSS item 5a\u002F5b 1-4), presence of neglect\u002Finattention (NIHSS item 11 1-2), atrial fibrillation, cohabitation status and pre-stroke functional level twill be identified in the Swedish national stroke registry, Riksstroke, and used for comparison.",[142,29,143],"Stroke Acute","TIA",[145,146,147,148],"Stroke","wearable","indication","sensor","2026-06-29",{"date":122,"type":34},{"date":152,"type":34},"2024-09-05",{"date":154,"type":23},"2027-12-31",{"name":156,"class":67},"Region Skane",{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":24,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100539105","raft---pace-ablate-100539105","NCT06299514","RAFT - Pace &Ablate","Resynchronization for Ambulatory Heart Failure Trial in Patients With Chronic Atrial Fibrillation - Pharmacological Rate Control vs. Pace and Ablate With Conduction System Pacing","RAFT-P&A RCT","Inclusion Criteria:\n\n1. Patients with permanent AF\u002Fpersistent AF (in AF)\n2. Patients with NYHA Class II -IVa HF symptoms\n3. Guideline driven medical therapy (GDMT) for HF for at least 3 months:\n\n   * for those \\\u003C 75 years of age with an NT-proBNP of ≥ 600 ng\u002FL\n   * for those ≥ 75 years of age with an NT-proBNP ≥ 900 ng\u002FL, or ≥ 600 ng\u002FL if the patient has had a HF hospitalization within 1 year\n\nExclusion Criteria:\n\n1. In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days\n2. Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year\n3. Acute coronary syndrome \\\u003C4 weeks or coronary revascularization \\\u003C3months\n4. Unable or unwilling to provide informed consent\n5. Uncorrected primary valvular disease or prosthetic tricuspid valve\n6. Restrictive, hypertrophic, or irreversible form of cardiomyopathy\n7. Severe pulmonary diseases requiring oxygenation\n8. Patients with a known history of WHO Class I pulmonary hypertension (PH) which includes PH associated with CVD, collagen vascular disease, congenital shunts, cirrhosis and portal hypertension, HIV, hemoglobinopathies, schistosomiasis or drug-associated PH as well as those with high suspicion of irreversible pulmonary hypertension\n9. Patients enrolled in competitive clinical trials that will affect the objectives of this study\n10. Existing CRT\u002FBiVP\n11. Patients who are pregnant\n12. Guideline indication for CRT\n13. More than 20% pacing with an existing pacemaker\n14. Severe mobility limitations (ex. wheelchair bound and severe neurological conditions that limit mobility)",{"count":166,"type":23},600,[26],"Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some patients find it difficult to tolerate medications and suffer side effects from these treatments. In these instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker.\n\nA complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). There is not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of CSP with AV node ablation to optimal medical therapy for treating AF.",[29,170,171,172],"Heart Failure","Pacemaker","Arrhythmia Atrial",{"date":124,"type":34},{"date":175,"type":34},"2024-04-25",{"date":177,"type":23},"2029-12-31",{"name":179,"class":67},"Habib Khan",12,{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":189,"sex":18,"minAge":190,"maxAge":20,"enrollmentInfo":191,"targetDuration":4,"studyType":24,"phases":193,"briefSummary":194,"conditions":195,"keywords":200,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":68},"100639438","uppsala-self-screening-of-cardiovascular-health-100639438","NCT07614659","Uppsala Self-Screening of Cardiovascular Health","Uppsala Self-Screening of Cardiovascular Health: A Randomized Controlled Trial of Home-Based Multimodal Cardiovascular Screening Versus Usual Care in Middle-Aged and Older Adults","U-SCREEN","Inclusion Criteria:\n\n* Resident in Region Uppsala, Sweden\n* Turning 50, 55, 60, 65, 70 or 75 years during recruitment period\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Protected identity",true,"50 Years",{"count":192,"type":23},45000,[26],"U-SCREEN is a randomized controlled trial evaluating whether systematic home-based multimodal screening for cardiovascular risk conditions, offered to residents in Region Uppsala turning 50, 55, 60, 65, 70 or 75 years of age, can identify clinically actionable cardiovascular risk factors more effectively than usual care. Participants randomized to the screening arm receive a home blood pressure measurement device, a dried blood spot sampling kit (for ApoB, HbA1c and creatinine), and a digital questionnaire. The control arm receives usual care. Recruitment runs 2024-2027 with a target identification of 10,000 cardiovascular risk conditions.",[196,197,198,199,29,83],"Cardiovascular Diseases","Hypertension","Dyslipidemias","Diabetes Mellitus",[201,202,203,204,205,206,207],"Population screening","Cardiovascular prevention","Home blood pressure monitoring","Dried blood spot","Digital health","Pragmatic trial","Register-based randomized controlled trial","2026-06-26",{"date":122,"type":34},{"date":211,"type":34},"2025-02-01",{"date":213,"type":23},"2037-12",{"name":215,"class":67},"Johan Sundström",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":24,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":238},"100555320","feasibility-study-of-the-faraflex-mapping-and-pfa-system-100555320","NCT06510556","Feasibility Study of the FARAFLEX Mapping and PFA System","Feasibility Study of the FARAFLEX Mapping and Pulsed Field Ablation (PFA) System in the Treatment of Persistent Atrial Fibrillation","ELEVATE-PF","Inclusion Criteria:\n\n1. Age ≥ 18 years of age, or older if required by local law\n2. Symptomatic, documented, Persistent AF or Paroxysmal AF\n3. Willing and capable of providing informed consent\n4. Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center\n\nExclusion Criteria:\n\n1. Atrial exclusions - Any of the following atrial conditions:\n\n   * Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non indexed volume \\>100 ml (by MRI, CT or TTE report or physician note)\n   * Any prior atrial endocardial, epicardial or surgical ablation procedure for atrial arrhythmia other than ablation for right sided SVT\n   * Current atrial myxoma\n   * Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)\n   * Current left atrial thrombus\n2. Cardiovascular exclusions - Any of the following CV conditions:\n\n   * History of sustained ventricular tachycardia or any ventricular fibrillation AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible \u002F non-cardiac causes\n   * Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, closure device, patch, or patent foramen ovale occluder, LA appendage closure, device or occlusion\n   * Valvular disease that is symptomatic or is the cause of heart failure.\n   * Hypertrophic cardiomyopathy\n   * Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty\n   * Known inability to obtain vascular access or other contraindication to femoral access\n   * Rheumatic heart disease\n   * Awaiting cardiac transplantation or other cardiac surgery within the next 12 months\n   * Known allergic drug reaction to nitroglycerin1\n   * Known severe non-revascularizable coronary disease\n   * Pre-existing right coronary artery stent and left circumflex artery\n3. Any of the following conditions at baseline:\n\n   * Heart failure associated with NYHA Class IV\n   * LVEF \\\u003C 40%\n   * Uncontrolled hypertension (SBP \\> 160 mmHg or DBP \\> 95 mmHg on two (2) BP measurements at baseline assessment\n   * Severe right ventricular dysfunction with documented echocardiography and\u002For hemodynamic data.\n4. Any of the following events within 90 Days of the Consent Date:\n\n   * Myocardial infarction (MI), unstable or Prinzmetal angina or coronary intervention\n   * Any cardiac surgery\n   * Heart failure hospitalization\n   * Pericarditis or symptomatic pericardial effusion\n   * Gastrointestinal bleeding\n   * Stroke, TIA, or intracranial bleeding\n   * Any non-neurologic thromboembolic event\n   * Carotid stenting or endarterectomy\n5. Known coagulopathy disorder (e.g. von Willibrand's disease, hemophilia)\n6. Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation.\n7. Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period\n8. Any of the following health conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation, including but not limited to:\n\n   * Body Mass Index (BMI) \\> 42.0\n   * Solid organ or hematologic transplant, or currently being evaluated for a transplant\n   * Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis\n   * Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen\n   * Renal insufficiency if an estimated glomerular filtration rate (eGFR) is \\\u003C 30 mL \u002F min \u002F 1.73 m2, or with any history of renal dialysis or renal transplant\n   * Active malignancy at enrollment (other than squamous cell carcinoma)\n   * Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration\n   * Active systemic infection\n   * Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (\\>30 pauses per hour)\n   * Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure\n\n10\\. Predicted life expectancy less than one (1) year 11. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility 12. Any of the following congenital conditions:\n\n* Congenital heart disease with any clinically significant residual anatomic or conduction abnormality\n* History of known congenital methemoglobinemia\n* History of known G6PD deficiency\n\nELEVATE-COR (additional) Eligibility Criteria:\n\nInclusion Criteria:\n\n1. Meets all inclusion criteria according to the ELEVATE-PF Protocol\n2. Planned for adjunctive CTI ablation\n3. Willing and capable of participating in all assessments and testing associated with this sub-study protocol.\n\nExclusion Criteria:\n\n1. Meets any of the exclusion criteria outlined in the ELEVATE-PF Protocol\n2. Pre-existing right coronary artery stent and\u002For left circumflex artery stent\n3. Known severe non-revascularizable coronary disease\n4. Moderate to severe coronary artery disease that in the opinion of the investigator would put the patient at increased risk\n5. Known calcium score ≥1000\n6. Renal insufficiency if an estimated glomerular filtration rate (eGFR) is \\\u003C 30 mL \u002F min \u002F 1.73 m2, or with any history of renal dialysis or renal transplant\n7. Contraindication to IVUS\n8. Body Mass Index (BMI) \\> 35.0",{"count":225,"type":23},250,[26],"The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or symptomatic Paroxysmal Atrial Fibrillation (PAF).",[29,229,230],"Persistent Atrial Fibrillation","Paroxysmal AF",{"date":149,"type":34},{"date":233,"type":34},"2025-02-17",{"date":235,"type":23},"2027-09-15",{"name":237,"class":41},"Boston Scientific Corporation",4,{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":24,"phases":248,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":4},"100480998","phase-4-pragmatic-amiodarone-trial-to-reduce-postoperative-atrial-fibrillation-in-patients-undergoing-cardiac-surgery-100480998","NCT05543278","Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery","PATRONUS","Inclusion Criteria:\n\n* \\>= 18 years of age\n* All genders\n* All non-coronary artery bypass cardiac surgery patients\n* Preoperative normal sinus rhythm\n\nExclusion Criteria:\n\n* Pre-existing atrial fibrillation or atrial arrhythmias\n* Pre-existing heart block\n* Cardiogenic shock\n* Sick sinus syndrome\n* Marked sinus bradycardia\n* Preoperative amiodarone use\n* Contraindication to amiodarone use\n\n  * PR interval \\> 240 ms\n  * QTc \\> 550 ms\n  * 2nd or 3rd degree heart block\n  * Liver impairment (INR \\> 1.7, AST\u002FALT \\> 2x normal)\n  * Uncontrolled hyperthyroidism or hypothyroidism\n  * Interstitial lung disease\n  * Pregnancy and\u002For breastfeeding\n  * Known hypersensitivity to any components of amiodarone, including iodine\n* Emergent operation\n* Planned MAZE or Pulmonary Vein Isolation procedure",{"count":247,"type":23},242,[249],"PHASE4","Postoperative atrial fibrillation is quite common after cardiac surgery with up to 1 in 3 patients experiencing this abnormal heart rhythm. Amiodarone, a medication commonly used to treat atrial fibrillation, has been previously shown to be an effective prophylactic agent at decreasing the occurrence of postoperative atrial fibrillation in patients who underwent coronary artery bypass surgery. However, despite many studies which have demonstrated its effectiveness, it has not been widely used due to the concern of side effects that can occur such as slow heart rate, low blood pressure, and lung toxicity. We have designed a study to test the effectiveness and safety of a short course of postoperative prophylactic amiodarone for patients undergoing non-coronary artery bypass cardiac surgery. We hypothesize that patients who receive the prophylactic amiodarone will have decreased rates of postoperative atrial fibrillation without significantly increased side effects compared to patients who receive the standard postoperative care after non-coronary artery bypass cardiac surgery.",[252,29],"Surgery, Cardiac",[254,255],"Postoperative atrial fibrillation","POAF",{"date":122,"type":34},{"date":258,"type":23},"2027-01",{"date":260,"type":23},"2028-12",{"name":262,"class":67},"Massachusetts General Hospital",{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":24,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":282},"100450615","the-conform-pivotal-trial-100450615","NCT05147792","The CONFORM Pivotal Trial","An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendage Occlusion","Inclusion Criteria:\n\n1. Male or non-pregnant female aged ≥18 years\n2. Documented non-valvular AF (paroxysmal, persistent, or permanent)\n3. High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3\n4. Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation\n5. Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.\n6. Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team using a shared decision-making process in accordance with standard of care\n7. Able to comply with the protocol-specified medication regimen and follow-up evaluations\n8. The subject (or legally authorized representative, where allowed) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)\u002FRegional Ethics Board (REB)\u002FEthics Committee (EC).\n\nExclusion Criteria:\n\n1. Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.\n2. Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., atrial septal defect (ASD) requiring closure, high-risk patent foramen ovale (PFO) requiring closure, a highly mobile inter-atrial septal aneurysm precluding a safe TSP, presence of a PFO\u002FASD closure device, history of surgical ASD repair or history of surgical LAAO closure)\n3. Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)\n4. A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or prosthetic mechanical heart valve)\n5. History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and\u002For anticoagulant therapy is contraindicated\n6. Documented active systemic infection\n7. Symptomatic carotid artery disease (defined as \\>50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is \\\u003C50% stenosis noted at the site of prior treatment\n8. Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or major non-cardiac interventional or surgical procedure\n9. Recent (within 30 days of index procedure) stroke or transient ischemic attack\n10. Recent (within 30 days of index procedure) myocardial infarction\n11. Vascular access precluding delivery of implant with catheter-based system\n12. Severe heart failure (New York Heart Association Class IV)\n13. Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any prosthetic mechanical valve implant\n14. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2 (by the Modification of Diet in Renal Disease equation)\n15. Platelet count \\\u003C75,000 cells\u002Fmm3 or \\>700,000 cells\u002Fmm3, or white blood cell count \\\u003C3,000 cells\u002Fmm3\n16. Known allergy, hypersensitivity or contraindication to aspirin, heparin, or that would preclude any P2Y12 inhibitor therapy, or to device materials (e.g., nickel, titanium), or the subject has contrast sensitivity that cannot be adequately pre-medicated\n17. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial\n18. Unable to undergo general anesthesia\n19. Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years\n20. A condition which precludes adequate transesophageal echocardiographic assessment\n\nEcho exclusion criteria:\n\n1. Left atrial appendage anatomy which cannot accommodate a commercially available control device or the CLAAS Implant per manufacturer IFU (e.g., the anatomy and sizing must be appropriate for both the investigational (CLAAS) and a commercially available device in order to be enrolled in the trial)\n2. Intracardiac thrombus or dense spontaneous echo contrast consistent with thrombus, as visualized by TEE\n3. Left ventricular ejection fraction (LVEF) \\\u003C30%\n4. Moderate or large pericardial effusion \\>10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology\n5. Atrial septal defect that warrants closure\n6. High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion \\>15 mm or length \\> 15 mm) or large shunt (early \\[within 3 beats\\] and\u002For substantial passage of bubbles, e.g., \\>20)\n7. Moderate or severe mitral valve stenosis (mitral valve area \\\u003C1.5 cm2)\n8. Complex atheroma with mobile plaque of the descending aorta and\u002For aortic arch\n9. Evidence of cardiac tumor",{"count":271,"type":23},1600,[26],"The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant.",[29,145],{"date":149,"type":34},{"date":277,"type":34},"2022-05-26",{"date":279,"type":23},"2031-12",{"name":281,"class":41},"Conformal Medical, Inc",92,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":290,"targetDuration":292,"studyType":52,"phases":4,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":303},"100447790","tracking-results-of-ablations-to-combat-af-registry-generation-2-100447790","NCT05111015","Tracking Results of Ablations to Combat AF Registry Generation 2","TRAC-AF","Inclusion Criteria:\n\n1. Patient has been scheduled by physician(s) to undergo or has undergone cardiac ablation procedure(s)\n2. Patient is willing to provide informed consent\n3. Patient whose age is 18 years or above, or of legal age to give informed consent specific to state and national law\n\nExclusion Criteria:\n\n1\\. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol.",{"count":291,"type":23},10000,"10 Years","The primary objective of the TRAC-AF Registry is to capture real-world safety and effectiveness data on AtriCure devices used to conduct open concomitant and\u002For hybrid ablation, and management of the LAA concomitant to a cardiac ablation.",[29],[29],{"date":149,"type":34},{"date":298,"type":34},"2024-03-11",{"date":300,"type":23},"2040-01",{"name":302,"class":41},"AtriCure, Inc.",29,{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":18,"minAge":310,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":68},"100430068","assessing-the-burden-of-perioperative-atrial-fibrillation-in-patients-undergoing-cardiac-surgery-100430068","NCT04880265","Assessing the Burden of Perioperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery","Inclusion Criteria:\n\n* Elective open heart surgery\n* Age \\> 20 years\n\nExclusion Criteria:\n\n* Refusal to participate (patient or health care proxy)\n* Participation in other pharmacological trials\n* Lack of data or poor data quality which cannot be analyzed for any heart rhythm in 80% of the postoperative study period.","20 Years","90 Years",{"count":313,"type":23},150,"Background and Significance:\n\nIn the United States approximately 220,000 patients undergo cardiac surgery per annum. Among potential complications, the incidence of atrial fibrillation (AF) is estimated at 30 - 60 %, and therefore presents the most common adverse event after cardiac surgery. Multiple complications may be associated with AF: Patients are usually subject to an increased length-of-stay in the intensive care unit and in the hospital. Furthermore, the risk for stroke and development of long-term AF is elevated, while further anticoagulation is required putting the patient at risk for bleeding. On average, an additional $10,000 - $20,000 is spent for each patient with AF. However, the exact burden of postoperative AF still remains unknown.\n\nSpecific Aims of Research Project:\n\n1. To collect data from an electrocardiogram (EKG) monitoring patch, we aim to accurately determine the prevalence of atrial fibrillation in patients undergoing cardiac surgery at our center.\n2. To collect data on epidemiological characteristics to investigate risk factors for developing perioperative atrial fibrillation in patients undergoing cardiac surgery. This will allow us to create robust risk prediction models.",[29,316],"Cardiac Surgery",[318],"Wearable Device",{"date":122,"type":34},{"date":321,"type":34},"2021-09-14",{"date":323,"type":23},"2030-05",{"name":325,"class":67},"Brigham and Women's Hospital",{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":24,"phases":336,"briefSummary":337,"conditions":338,"keywords":339,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":68},"100594581","deliver-more-applications-for-more-durable-pulmonary-vein-isolation-100594581","NCT07021313","Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation","DOPPIO","Inclusion Criteria:\n\n* Be scheduled for PVI with the use of the FARAPULSE catheter ablation system AND\n* Have paroxysmal atrial fibrillation (PAF) documented in the last 6 months prior to enrolment OR\n* Had persistent atrial fibrillation but maintained in SR or converted to paroxysmal by antiarrhythmic drugs with no more than 1 cardioversion beyond 7 days in the past\n\nExclusion Criteria:\n\n* Cerebrovascular accident (CVA) in the last 6 months\n* More than moderate valvular disease that would require intervention\n* Cardiac catheter\u002Fsurgical intervention in the last 3 months or scheduled\n* Atrial septal defect (ASD)\u002F patent foramen ovale (PFO) closure in the past\n* Left atrial appendage (LAA) closure in the past\n* Mechanical mitral valve\n* Non-adherence to oral anticoagulation in the 3 weeks prior to ablation\n* Renal disease with known eGFR\\\u003C45 ml\n* Left atrial volume index (LAVI) \\>50 ml\u002Fm2 or left atrial diameter (LAD) \\>50 mm\n* Known contra-indication for catheter ablation\n* Known contra-indication for deep sedation or general anesthesia\n* Known pregnancy","80 Years",{"count":335,"type":23},378,[26],"Pulmonary vein isolation (PVI) by catheter ablation (CA) has become a widely accepted interventional treatment for patients with symptomatic atrial fibrillation (AF) despite anti-arrhythmic drugs (AAD). Classic thermal ablation modalities use radiofrequency energy or cryo-energy to create cardiac tissue lesions. Irreversible electroporation (IRE) using pulsed field energy (PFA) is a novel technology for cardiac tissue ablation. Initial studies have shown favorable outcome data in patients with AF treated by performing PVI using PFA. However, the freedom of AF has not yet proven superior to existing thermal ablation methods and appears similarly associated with suboptimal lesion durability, leading to electrical reconnection. The purpose of this study is to determine if freedom of atrial fibrillation may be improved by delivering more and better targeted pulsed field ablations.",[29],[340,29],"Pulsed Field Ablation","2026-06-25",{"date":122,"type":34},{"date":344,"type":34},"2025-06-20",{"date":346,"type":23},"2028-06",{"name":348,"class":67},"R&D Cardiologie",{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":189,"sex":18,"minAge":357,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":24,"phases":360,"briefSummary":361,"conditions":362,"keywords":363,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":68},"100589389","the-effectiveness-of-patch-based-screening-for-pre-symptomatic-atrial-fibrillation-to-improve-patient-outcome-100589389","NCT06953778","The Effectiveness of Patch-Based Screening for Pre-Symptomatic Atrial Fibrillation to Improve Patient Outcome","CSP #2037S - Veterans Affairs Learning Health System Initiative to Assess Novel Screening vs. Usual Care and Treatment With Apixaban vs. Rivaroxaban in Veterans With Atrial Fibrillation (VALIANT-AF-S) Trial","VALIANT-AF-S","Inclusion Criteria:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female, age \\>=65 years\n2. CHA2DS2-Vasc score \\>=3. The score is comprised of age (2 points for 75, 1 point for 65-74), sex (1 point for female), history of stroke, TIA, or systemic embolism (2 points), and history of heart failure, hypertension, vascular disease (including MI, peripheral artery disease, or aortic plaque), or diabetes (1 point each).\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Current use of anticoagulation\n2. Diagnosis of AF (from administrative records or per patient during consent)\n3. Cardio-thoracic surgery in the prior 3 months\n4. Presence of pacemaker, implantable defibrillator, or implanted cardiac monitor\n5. Clinically significant allergy to adhesives, as reported by the patient during screening for trial enrollment\n6. Planned use of a brain or spinal-cord stimulator, TENS unit, or MRI scan during the period when the Zio Patch will be worn","65 Years",{"count":359,"type":23},24060,[26],"* The goal of the screening trial is to determine whether early screening for atrial fibrillation improves outcomes, including lowering the chance of death, hospitalization for stroke, blood clots, heart failure, heart attack, and severe bleeding reduces the risk of stroke or heart failure.\n* Atrial fibrillation is a common heart condition in which one of the heart chambers doesn't follow a normal rhythm. Blood clots can form as a result, and they can travel to the brain and cause strokes, or to other organs.\n* Almost everyone with atrial fibrillation is treated with drugs called anticoagulants (\"blood thinners\") to reduce the risk of stroke. These drugs also increase the risk of bleeding.\n* Testing for atrial fibrillation is usually done for patients who have symptoms of an irregular or unusually fast or slow heartbeat, often called \"palpitations\" or a sensation of the heart pounding or stopping for a short period of time.\n* What is not known is whether screening people who do not have symptoms of atrial fibrillation, but who are at above-average risk of getting atrial fibrillation, will reduce death, hospitalization for stroke, blood clots, heart failure more than it increases hospitalization for severe bleeding.\n* People who participate in the trial who are selected by chance to receive screening will wear a small heart-rate monitor (Zio Patch) on their skin for 14 days and then return it to the manufacturer. Their doctors will be notified about the results and will make decisions about any treatment to recommend.\n* The screening trial is expected to enroll about 24,000 VA patients nationwide and to last 7 years, but each person's active participation in the trial is completed after sending in the Zio Patch. After that, the study team will just collect information from the participant's electronic medical records.",[29],[29,364],"Ischemic Stroke",{"date":122,"type":34},{"date":367,"type":23},"2027-03-08",{"date":369,"type":23},"2033-10-03",{"name":371,"class":372},"VA Office of Research and Development","FED",{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":24,"phases":382,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":398},"100366007","phase-3-anticoagulation-for-new-onset-post-operative-atrial-fibrillation-after-cabg-100366007","NCT04045665","Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG","PACES","Inclusion Criteria:\n\n* Patients of age ≥18 years who undergo isolated CABG for coronary artery disease\n* POAF that persists for \\>60 minutes or is recurrent (more than one episode) within 7 days after the index CABG surgery\n\nExclusion Criteria:\n\n* Clinical history of either permanent, persistent or paroxysmal atrial fibrillation\n* Any pre-existing clinical indication for long-term OAC\n* Any absolute contraindication to OAC\n* Planned use of post-operative dual antiplatelet therapy (DAPT)\n\n  a. This includes, but is not limited to, patients with recent PCI with drug-eluting or bare-metal stent.\n* Cardiogenic shock\n* Major perioperative complication\\* occurring between CABG and randomization\n\n  a. including, but not limited to, stroke, TIA, MI, major bleeding (BARC type 4 bleeding), severe sepsis, renal failure requiring dialysis, or need for reoperation due to bleeding (e.g. pericardial tamponade).\n* Concomitant left atrial appendage closure during CABG\n* Concomitant valve surgery during CABG or prior valve surgery (including aortic, mitral, tricuspid or pulmonary)\n* Concomitant mitral valve annuloplasty during CABG\n* Concomitant carotid artery endarterectomy during CABG\n* Concomitant aortic root replacement during CABG\n* Concomitant surgery for AF during CABG\n* Liver cirrhosis or Child-Pugh Class C chronic liver disease\n* Pharmacologic therapy with an investigational drug or device within 30-days prior to randomization or plan to enroll patient in an investigational drug or device trial during participation in this trial\n* Pregnancy at the time of randomization\n* Unable or unwilling to provide inform consent\n* Unable or unwilling to comply with the study treatment and follow-up\n* Existence of underlying disease that limits life expectancy to less than one year",{"count":381,"type":23},3200,[383],"PHASE3","The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery.\n\nAll patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.",[29,145,386],"Bleeding",[388,389,390],"Anticoagulation","Antiplatelet Therapy","Post Operative Atrial Fibrillation",{"date":208,"type":34},{"date":393,"type":34},"2019-12-13",{"date":395,"type":23},"2026-08-31",{"name":397,"class":67},"Icahn School of Medicine at Mount Sinai",106,{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":420},"100568842","concomitant-left-atrial-appendage-closure-and-pulsed-field-ablation-asia-100568842","NCT06686485","cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia","OPTION-A","Inclusion Criteria:\n\n1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN for LAAC, per physician medical judgement and as per hospitals' standard of care.\n2. Subjects who are willing and able to provide informed consent.\n3. Subjects who are willing and able to participate in all testing associated with this clinical study at an approved clinical investigational center.\n4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.\n\nExclusion Criteria:\n\n1. Subjects who underwent prior AF ablation procedure.\n2. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible \u002F non-cardiac causes.\n3. Already surgically closed or otherwise excluded LAA.\n4. The LAA anatomy does not accommodate a Closure Device.\n5. Known or suspected atrial myxoma.\n6. Presence of intracardiac thrombus.\n7. Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an ASD\u002FPFO device.\n8. Subjects with a presence of a mechanical valve prosthesis in any position.\n9. Subjects with a myocardial infarction within 30 days prior to enrollment.\n10. Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment.\n11. Any planned electrical cardioversion within 30 days following LAAC device implant.\n12. Subjects with a known inability to obtain vascular access.\n13. Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy), active conditions (e.g. infection, bleeding disorder, unstable angina) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present\\*.\n14. Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina) are present.\n15. Subjects with any contraindications to short term use of anticoagulation therapy, or aspirin for conditions different from atrial fibrillation.\n16. Subjects who are pregnant or planning to be pregnant.\n17. Subjects with a life expectancy of ≤ 1 year per investigator's opinion.\n18. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be reviewed by the sponsor to determine eligibility.",{"count":407,"type":23},433,"Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care during the same procedure.",[410,29,411,412],"Concomitant Procedures","PFA","LAAC","2026-06-22",{"date":341,"type":34},{"date":416,"type":34},"2025-03-18",{"date":418,"type":23},"2029-10-31",{"name":237,"class":41},37,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":333,"enrollmentInfo":429,"targetDuration":4,"studyType":24,"phases":431,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":441},"100633485","a-study-of-varipulse-catheter-in-participants-with-persistent-atrial-fibrillation-undergoing-pulmonary-vein-and-superior-vena-cava-isolation-100633485","NCT07527299","A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation","Assessment of the Safety and Effectiveness of the VARIPULSE™ Catheter System in the Treatment of Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein (With or Without Posterior Wall Isolation) and Superior Vena Cava Isolation: A Randomized Controlled Trial","SPAA PFA","Inclusion criteria:\n\n* Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days in duration and less than 365 days in duration, documented by: i. A physician's note documenting diagnosis of symptomatic PsAF, as defined above; and ii. Two electrocardiograms (ECGs) showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than (\\>) 365 days prior to enrollment); or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days\n* Participant is aged 18 - 80 years at the time of informed consent\n* Participant is willing and capable of providing informed consent\n* Participant is able and willing to comply with all pre-, post- and follow-up testing and requirement\n\nLeft atrial appendage occlusion (LAAO) concomitant subset:\n\n\\- Participant is clinically indicated for a LAAO procedure\n\nExclusion criteria:\n\n* Participant has continuous AF \\> 365 days (longstanding persistent AF)\n* Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)\n* Participant has had previous surgical or catheter ablation for AF\n* Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)\n* Participant has severe dilatation of the LA (left atrial diameter \\[LAD\\] \\> 50 millimeters \\[mm\\]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment\n* Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure\n* Participant has severely compromised left ventricular ejection fraction (left ventricle ejection fraction \\[LVEF\\] less than \\[\\\u003C\\] 40 percent \\[%\\]) confirmed by imaging performed within 180 days prior to enrollment\n* Participant has uncontrolled heart failure or New York heart association (NYHA) Class III or IV functional classification\n* Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)\n* Participant has had a thromboembolic event (including transient ischemic attack \\[TIA\\]) within the past 180 days prior to enrollment\n* Participant has had a percutaneous coronary intervention or acute myocardial infarction (MI) within past 60 days prior to enrollment\n* Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment\n* Participant has had valvular cardiac surgical\u002Fpercutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)\n* Participant has unstable angina within past 6 months prior to enrollment\n* Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure\n* Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms\n* Participant has a significant congenital anomaly (for example, atrial septal defects \\[ASDs\\]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study\n* Participant has an existing diagnosis of pulmonary vein stenosis (PVS)\n* Participant has a pre-existing hemi-diaphragmatic paralysis\n* Participant has an acute illness, active systemic infection, or sepsis\n* Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation\n* Participant has severe mitral regurgitation (Regurgitant volume greater than or equal to \\[\\>=\\] 60 milliliters \\[mL\\]\u002Fbeat, Regurgitant fraction \\>= 50%, and\u002For Effective regurgitant orifice area \\>= 0.40 square centimeter \\[cm\\^2\\])\n* Participant has an implanted metal cardiac device (other than coronary stents, implanted pacemaker, implantable cardioverter-defibrillator \\[ICD\\], implantable loop recorder \\[ILR\\]) that may interfere with the pulsed field (PF) energy field\n* Participant has a condition that precludes vascular access (such as inferior vena cava \\[IVC\\] filter) - Participant is currently enrolled in an investigational study evaluating another device or drug\n* Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation\n* Participant has a life expectancy of less than 365 days\n* Participant has contraindications for the devices used in the study, as indicated in the respective instructions for use (IFUs)\n* Participant has contraindications for the ablation of the SVC\n\nLAAO concomitant subset:\n\n* Participant is contraindicated for a LAAO procedure per the instructions of use of the planned LAAO device\n* Participant with prior LAAO procedure (attempted or successful)",{"count":430,"type":23},920,[26],"The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; PVI and SVCI), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation.",[29],"2026-06-18",{"date":413,"type":34},{"date":437,"type":23},"2026-08-05",{"date":439,"type":23},"2031-08-04",{"name":40,"class":41},19,{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":18,"minAge":357,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":24,"phases":451,"briefSummary":452,"conditions":453,"keywords":454,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":460,"locationsCount":461},"100589385","phase-4-comparing-the-safety-and-efficacy-of-apixaban-and-rivaroxaban-100589385","NCT06953726","Comparing the Safety and Efficacy of Apixaban and Rivaroxaban","CSP #2037T - Veterans Affairs Learning Health System Initiative to Assess Novel Screening vs. Usual Care and Treatment With Apixaban vs. Rivaroxaban in Veterans With Atrial Fibrillation (VALIANT-AF-T) Trial","VALIANT-AF-T","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female Veteran, aged 22 years or older\n2. Diagnosis of atrial fibrillation (AF) or atrial flutter (AFL) and currently taking either apixaban or rivaroxaban.\n3. CHA2DS2-Vasc of 3 or more\n4. Ability to take oral medication and self-reported willingness to adhere to the prespecified apixaban or rivaroxaban regimen\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study; notably use of antiplatelet agents or prior OAC use will not be an exclusion criterion:\n\n1. Current use of oral or injectable anticoagulation, without ability to switch to the assigned study medication\n2. Another indication for anticoagulation, such as pulmonary embolism\n3. Contraindication to oral anticoagulation\n4. Known bleeding diathesis\n5. Documented current pregnancy or lactation in the EHR or self-reported current pregnancy or lactation\n6. Known allergic reactions or intolerance to apixaban or rivaroxaban\n7. Most recent estimated glomerular filtration rate (eGFR) is \\\u003C 30 mL\u002Fminute\u002F1.73m2. An eGFR result must have been obtained within 18 months before randomization.\n8. Known mechanical heart valve\n9. Known moderate-severe mitral stenosis\n10. Known history of left atrial occlusion, excision, or ligation\n11. Current or planned use of systemic ritonavir, itraconazole, or ketoconazole (topical use of ketoconazole only is allowed)\n12. Cardiac or thoracic surgery in the past 3 months",{"count":291,"type":23},[249],"* The trial will compare two anticoagulants (\"blood thinners\") that are currently used in the VA and are considered standard care to prevent strokes in patients with atrial fibrillation. The two most commonly-used anticoagulants will be compared: apixaban (Eliquis) and rivaroxaban (Xarelto). They are considered by many doctors to have similar benefits and risks, but no one knows for sure.\n* The trial only enrolls patients with a diagnosis of atrial fibrillation (\"A Fib\") or atrial flutter. Most participants will be age 65 or older, and should already be taking apixaban or rivaroxaban.\n* The investigators will measure, in about 10,000 VA patients nationally, whether the rates of stroke, major bleeding, or death differ between these two drugs.\n* The trial will last about 7 years, but after the first prescription, all information will be collected from electronic medical records.",[29],[29,364,386,455],"Major bleeding",{"date":413,"type":34},{"date":458,"type":34},"2026-06-01",{"date":369,"type":23},{"name":371,"class":372},5,{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":471,"conditions":472,"keywords":475,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":489},"100641807","volta-medical-ai-software-in-real-world-during-af-ablation-100641807","NCT07621055","VOLta Medical AI-software in REal-World During AF Ablation","Real-World Experience of Volta Medical AI-software During AF Ablation Using Next-generation Mapping and Ablation Technologies","VOLTAIRE-AF","Inclusion Criteria:\n\n1. Patient aged 18 years or older.\n2. Patient candidate for catheter ablation to treat paroxysmal or persistent atrial fibrillation, atrial tachycardia, de novo or after one or several previous ablation procedures, and for which the investigator considers using Volta AF-Xplorer II.\n3. Patient able and willing to provide written informed consent to participate in the study.\n4. Only for France: Patient affiliated to the French social security system.\n\nExclusion Criteria:\n\n1. Contraindication to AF\u002FAT catheter ablation using RF and\u002For PFA.\n2. Patient who is or could potentially be pregnant.\n3. Person deprived of liberty or under guardianship.\n4. Person unable to undergo a medical monitoring for geographical, social or psychological reasons.\n5. Patient's refusal to participate in the study.\n6. Enrollment in a premarket clinical study evaluating device, drug or biologic product.",{"count":313,"type":23},"This PMCF study \"VOLTAIRE-AF\" will allow to observe acute and long-term safety and performance outcomes of the last generation of Volta Medical AI software (Volta AF-Xplorer II) during AF ablation using next-generation mapping and ablation technologies over a 24-month follow-up and in \"real life\"clinical practice, without any imposed clinical workflow.",[29,473,474],"Atrial Arrhythmia","Arrhythmias, Cardiac",[476,477,478,479,480,481,473],"Volta AF-Xplorer II","Artificial Intelligence","Cardiac ablation","Medical Device","Software","Volta Medical","2026-06-17",{"date":413,"type":34},{"date":485,"type":34},"2026-06-16",{"date":487,"type":23},"2030-06",{"name":481,"class":41},3,{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":24,"phases":500,"briefSummary":501,"conditions":502,"keywords":503,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":303},"100514299","early-closure-of-left-atrial-appendage-for-patients-with-atrial-fibrillation-and-ischemic-stroke-despite-anticoagulation-therapy-100514299","NCT05976685","Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy","Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic StrokE Despite Anticoagulation Therapy","ELAPSE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Written informed consent\n* Permanent, persistent, or paroxysmal spontaneous AF previously known or diagnosed during the index hospitalization.\n* Recent (≤3 months) symptomatic ischemic stroke.\n* Active and ongoing anticoagulation therapy at stroke onset assessed based on medical history (i.e. any therapeutic oral anticoagulation therapy \\[Vitamin K antagonist\u002FDOAC according to prescription recommendations for AF; inadequate low-dose DOAC therapy allowed for inclusion\\] not stopped\u002Fpaused for \\>48 hours due to any reason, i.e. medical intervention or non-adherence).\n* Active or planned long-term therapy with DOAC\n\nExclusion Criteria:\n\n* Contraindications to DOAC therapy\n* Life expectancy \\\u003C1 year according to the opinion of the investigator\n* Stroke due to: Ipsilateral intra\u002Fextracranial high-grade stenosis, Isolated lacunar stroke, Other well-defined stroke aetiologies (i.e., endocarditis, vasculitis, Reversible Cerebral Vasoconstriction Syndrome \\[RCVS\\], Posterior Reversible Encephalopathy Syndrome \\[PRES\\], cerebral sinus venous thrombosis)\n* Previous persistent foramen ovale or atrial septum defect closure.\n* Rheumatic heart disease\n* Severe heart valve disease that requires treatment (severe aortic stenosis or regurgitation, severe mitral stenosis or regurgitation).\n* Contraindications for TEE (relevant esophageal varices, esophageal stricture, history of esophageal cancer).\n* Cardiac or non-cardiac surgical procedure within 30 days of randomization\n* Enrolled in another investigation of a cardiovascular device or investigating secondary prevention therapy.\n* Severely reduced Left Ventricular Ejection Fraction (LVEF) \\\u003C30%.\n* Severe renal impairment as described in the summary of medicinal product characteristics for the chosen DOAC (e.g. rivaroxaban, apixaban and edoxaban creatinine clearance \\\u003C15 ml\u002Fmin; dabigatran creatinine clearance \\\u003C30 ml\u002Fmin).\n* Hypertrophic cardiomyopathy\n* Intracardiac tumor\n* Ventricular thrombus\n* Acute cardiac decompensation\n* LAA is obliterated or surgically ligated\n* Persistent proximal LAA thrombus despite 4 weeks of anticoagulation (if a proximal thrombus in the LAA is found, anticoagulation with vitamin K antagonist (INR 2.5-3.5) may be started, and if the thrombus disappears, the patient may be eligible for LAAO)\n* Pregnancy or breastfeeding (pregnancy test in urine or blood to be performed at screening for women of childbearing potential)",{"count":499,"type":23},482,[26],"Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication. Direct oral anticoagulants (DOAC) reduce the risk of cardioembolism in patients with AF. Despite DOAC therapy, there is a significant residual stroke risk of 1-2%\u002Fyear. Recent data from the Swiss Stroke Registry found 38% of patients with AF and ischemic stroke were on prior anticoagulant therapy (approximately 400 patients per year in Switzerland). The investigators found in a prior observational study, that patients with AF who have ischemic stroke despite anticoagulation are at increased risk of having another ischemic stroke (HR 1.6; 95% confidence interval, CI 1.1-2.1). Combining observational data from 11 international stroke centres, the investigators found that the majority of ischemic strokes despite anticoagulation in patients with AF is \"breakthrough\" cardioembolism (76% of patients) and only a minority of 24% is related to other causes unrelated to AF. Optimal secondary prevention strategy is unknown. The investigators have conducted two independent observational studies including together \\>4000 patients but did not identify any strategy (e.g. switch to different DOAC, additional antiplatelet therapy) that seems superior. A recent randomized controlled trial on surgical occlusion of the left atrial appendage (LAAO) found that LAAO may provide additional protection from ischaemic stroke in addition to oral anticoagulation. Triggered by this finding, the investigators performed a matched retrospective observational study and found that patients with AF and stroke despite anticoagulation who received a combined mechanical-pharmacological therapy (DOAC therapy + LAAO) had lower rates of adverse outcomes compared to those with DOAC therapy alone. Therefore, the investigators hypothesize that in patients with AF and ischemic stroke despite anticoagulant therapy, LAAO in addition to anticoagulation with a DOAC is superior to DOAC therapy alone. The investigators propose an international, multi-center randomized controlled two-arm trial to assess the effect of LAAO in patients with AF suffering from strokes despite anticoagulation therapy and without competing stroke etiology. The investigators will use the PROBE design with blinded endpoint assessment. The investigators will enrol patients with non-valvular AF and a recent ischemic stroke despite anticoagulation therapy at stroke onset. Patients will be randomized 1:1 to receive LAAO + DOAC therapy (experimental arm) or DOAC therapy alone (standard treatment arm). The primary endpoint is the first occurrence of a composite outcome of recurrent ischemic stroke, systemic embolism and cardiovascular death during follow-up. Secondary outcomes include individual components of the primary composite outcome, safety outcomes (i.e. symptomatic intracranial haemorrhage, major extracranial bleeding, serious device- or procedure-related complication), functional outcome (modified Rankin Scale) and patient-oriented outcomes. The minimum follow-up is 6 months and all patients will receive follow-ups every 6 months until end of study, the maximal follow-up will be 48 months. Based on prior observational data from the investigators' group and others (5 observational studies, \\>5000 patients), the investigators estimate the proportion of patients with the primary outcome in the standard treatment arm to be 18% in the first year and 9% in the second year (=cumulative 27% after 2 years). A relative risk reduction of 40% at 2 years would be clinically relevant. Based on these assumptions and a log-rank test, the investigators would need 98 events for a power of 80% at an alpha-level of 5%. Assuming a recruitment rate of 52, 118, 156 and 156 patients in years 1 to 4, an additional 6 months of follow-up (mean follow-up time of 2.1 years) and a uniform drop-out rate of 7.5% per year, 482 patients would need to be enrolled. How to treat patients with an ischemic stroke despite anticoagulation is a major yet unresolved clinical dilemma. This trial has the potential to answer the question whether LAAO plus DOAC therapy is superior to current standard of care for patients with AF who have ischemic stroke despite anticoagulation.",[364,29],[145,504,505],"Direct oral anticoagulation","Left atrial appendage occlusion",{"date":482,"type":34},{"date":508,"type":34},"2024-05-01",{"date":510,"type":23},"2028-06-01",{"name":512,"class":67},"Insel Gruppe AG, University Hospital Bern",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":24,"phases":523,"briefSummary":524,"conditions":525,"keywords":529,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":538,"locationsCount":68},"100415858","phase-4-dual-antithrombotic-therapy-with-dabigatran-and-ticagrelor-in-patients-with-acs-and-non-valvular-af-undergoing-pci-100415858","NCT04695106","Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With ACS and Non-valvular AF Undergoing PCI","Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With Acute Coronary Syndrome and Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ADONIS-PCI)","ADONIS-PCI","Inclusion Criteria:\n\n* Male and female patients aged ≥18 years'\n* Patients with new-onset or pre-existing non-valvular AF that have been receiving oral anticoagulant treatment with dabigatran for at least 48 hours or were treatment naïve prior to PCI. AF may be paroxysmal, persistent or permanent, but must not be secondary to a reversible disorder such as MI, pulmonary embolism, recent surgery, pericarditis or thyrotoxicosis unless long-term treatment with an OAC is anticipated.\n* Patients presenting with ACS that had undergone a successful PCI with drug-eluting stent (DES) implantation or plain old balloon angioplasty within the previous 120 hours. ACS may be ST-elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), or unstable angina (UA). Successful treatment with PCI is defined as achievement of \\\u003C30% residual diameter stenosis of the target lesion assessed by visual inspection or quantitative coronary angiography and no in-hospital major adverse cardiac events (AMI or repeat coronary revascularisation of the target lesion). For ACS patients with ST-segment elevation, persistent ST-segment elevation of at least 0.1 mV in at least two contiguous leads or a new left bundle-branch block should be present. For ACS patients without ST-segment elevation, at least two of the following three criteria should be met: (i) ST-segment changes on electrocardiography, indicating ischemia; (ii) a positive test of a biomarker, indicating myocardial necrosis; or (iii) one of several risk factors (age ≥60 years; previous myocardial infarction or coronary artery bypass grafting; coronary artery disease with stenosis of ≥50% in at least two vessels; previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization; diabetes mellitus; peripheral arterial disease; chronic renal dysfunction, defined as a creatinine clearance of \\\u003C60 ml per minute per 1.73 m2 of body surface area).\n* The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and\u002For regulations.\n\nExclusion Criteria:\n\n* Mechanical or biological heart valve prosthesis;\n* PCI with bare-metal stent insertion;\n* Unsuccessful PCI (\\>30% residual stenosis of the target lesion);\n* Cardiogenic shock during current hospitalization;\n* Adverse bleeding or ischaemic event during current hospitalization;\n* Anaemia (haemoglobin \\\u003C10 g\u002FdL) or thrombocytopenia (platelet count \\\u003C100 x109\u002FL) at screening,\n* Severe renal impairment (creatinine clearance \\\u003C30mL\u002Fmin (estimated CrCl calculated by Cockcroft-Gault equation) at screening;\n* Active liver disease at screening defined as persistently elevated alanine aminotransferase (ALT) or aspartate transaminase (AST) \\>3-fold upper limit of normal (ULN)\n* Use of fibrinolytic agents within 24 hours of screening;\n* Gastrointestinal bleeding within 1 month prior to screening unless, in the opinion of the Investigator, the cause has been permanently eliminated (e.g., by surgery);\n* Major bleeding episode (reduction in the hemoglobin level of at least 2 g\u002FdL, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ), including life-threatening bleeding episode (symptomatic intracranial bleeding, bleeding with a decrease in the hemoglobin level of at least 5 g\u002FdL or bleeding requiring transfusion of at least 4 units of blood or inotropic agents or necessitating surgery) within 1 month prior to screening;\n* Stroke within 1 month prior to screening;\n* Major surgery within 1 month prior to screening;\n* Malignancy or radiation therapy within 6 months prior to screening unless, in the opinion of the Investigator, the estimated life expectancy is greater than 36 months;\n* History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding unless the causative factor has been permanently eliminated or repaired;\n* Hemorrhagic disorder or bleeding diathesis (e.g. von Willebrand disease, hemophilia A or B or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding, history of prolonged bleeding after surgery\u002Fintervention);\n* Past an organ transplant or patient on the waiting list for organ transplant;\n* Need for continued treatment with systemic ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John's Wort or any cytotoxic\u002Fmyelosuppressive therapy.\n* Need for continued treatment with non-steroidal anti-inflammatory drugs (NSAIDs);\n* Pre-menopausal women (last menstruation ≤1 year prior to screening) who: sre pregnant or breastfeeding or are not surgically sterile or are of childbearing potential and not practicing two acceptable methods of birth control, or do not plan to continue practicing an acceptable method of birth control throughout the trial. Acceptable methods of birth control are oral or parenteral (patch, injection, implant) hormonal contraception, which has been used continuously for at least one month prior to the first dose of study medication, intrauterine device or intrauterine system, double-barrier method of contraception (condom and occlusive cap or condom and spermicidal agent), male sterilization and complete sexual abstinence (if acceptable by local authorities). Periodic abstinence is not an acceptable method of contraception.\n* Known allergy to dabigatran, ticagrelor, clopidogrel, aspirin, or to the excipients used for the tables of the drugs;\n* Contraindications, in the Investigator's opinion to dabigatran, ticagrelor, clopidogrel, or aspirin;\n* Participation in another trial with an investigational drug or device within the past 30 days preceding the screening visit (patients participating in an observational study only will not be excluded);\n* Patients who are not willing or able to comply with the protocol requirements or considered unreliable by the Investigator concerning the requirements for follow-up during the study and\u002For compliance with study drug administration, who have a life expectancy less than the expected duration of the trial due to concomitant disease, or who have any condition which in the opinion of the Investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).",{"count":522,"type":23},1194,[249],"More than 25% of patients referred for diagnostic coronary angiography and percutaneous coronary intervention (PCI) due to acute coronary syndrome (ACS) suffer from non-valvular atrial fibrillation (AF). In this particular setting, balancing between the prevention of thrombosis and the risk of bleeding remains challenging. Oral anticoagulation (OAC) prevents stroke and systemic embolism, but has not been shown to prevent stent thrombosis (ST). Dual antiplatelet therapy (DAPT) reduces the incidence of recurrent ischemic events and ST, but is less effective in reducing the incidence of cardioembolic stroke associated with AF. A common guideline-supported practice is to combine three drugs (OAC, aspirin and clopidogrel) in a triple therapy, which is associated with high annual risk (up to 25%) of major bleeding. Thus, new therapeutic strategies are urgently needed to maintain the efficacy while improving the safety of treatment in patients with AF and ACS undergoing PCI.\n\nThis is a prospective, randomized, open-label, blinded-endpoint, non-inferiority trial. 1194 patients with non-valvular AF that had undergone successful PCI due to an ACS within the previous 120 hours will be randomized in 1:1 ratio to receive one of the two treatments: dual therapy with dabigatran (150 mg twice daily or 110 mg twice daily) and ticagrelor (90 mg twice daily for 1 month, followed by 60 mg twice daily up to 12 months), or standard therapy according to current guidelines triple therapy with dabigatran (150 mg b.i.d. or 110 mg b.i.d.) plus clopidogrel (75 mg o.d.) plus aspirin (75 mg o.d.) followed by double therapy depending on the bleeding and ischaemic risk. Study treatment will be continued for 12 months. The primary study end-point is the first major or clinically relevant non-major bleeding event (per ISTH), in a time-to-event analysis. The main secondary end-point is a composite efficacy end-point of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization (PCI or coronary artery bypass grafting) at 12 months.\n\nWe expect that dual antithrombotic therapy including reduced dose ticagrelor and dabigatran is at least non-inferior regarding bleeding risk and ischaemic protection, compared to the standard triple therapy in patients with AF and after ACS, treated with PCI.",[29,526,527,528],"Antithrombotic Therapy","Acute Coronary Syndrome","Percutaneous Coronary Interventions",[29,527,530,531,532],"Dabigatran","Ticagrelor","Antithrombotic therapy","2026-06-14",{"date":485,"type":34},{"date":536,"type":34},"2021-10-25",{"date":395,"type":23},{"name":539,"class":67},"Medical University of Gdansk",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":546,"targetDuration":548,"studyType":52,"phases":4,"briefSummary":549,"conditions":550,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":68},"100262768","left-atrial-appendage-occlusion-registry-laao-registry-100262768","NCT02699957","Left Atrial Appendage Occlusion Registry (LAAO Registry)","Inclusion Criteria:\n\n* Adult patients, 18 years and older, undergoing percutaneous or epicardial left atrial appendage occlusion procedures\n\nExclusion Criteria:\n\n* None",{"count":547,"type":23},3000,"2 Years","The Left Atrial Appendage Occlusion Registry (LAAO Registry™) is designed to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous and epicardial based left atrial appendage occlusion procedures to reduce the risk of stroke. Patient-level data will be submitted by participating hospitals on a quarterly basis to the American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR). The primary aims of the LAAO Registry are to optimize the outcomes and management of patients through the implementation of evidence-based guideline recommendations in clinical practice, facilitate efforts to improve the quality and safety for patients undergoing percutaneous and epicardial based left atrial appendage procedures, investigate novel quality improvement methods and provide risk-adjusted assessment of patients for comparison with nationwide NCDR data. The secondary purpose of the LAAO Registry is to serve as a rich source of clinical data to support assessments of short- and long-term safety, comparative and cost effectiveness research, and as a scalable data infrastructure for post market studies.",[29],"2026-06-12",{"date":553,"type":34},"2026-06-15",{"date":555,"type":4},"2015-12",{"date":557,"type":23},"2029-01",{"name":559,"class":67},"American College of Cardiology",{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":566,"targetDuration":567,"studyType":52,"phases":4,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":4},"100642212","globe-registry-globe-pulsed-field-system-registry-study-for-treating-patients-with-symptomatic-atrial-fibrillation-100642212","NCT07651852","Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation","Key Inclusion Criteria:\n\n* Patients with a planned ablation procedure using the commercially available Globe PF System\n\nKey Exclusion Criteria:\n\n* Patients whose life expectancy is 1 year or less\n* Contraindication to left atrial catheter ablation or PF ablation\n* Current enrollment in any investigational study of a medical device, biologic, or drug not pre-approved by Kardium",{"count":51,"type":23},"12 Months","This post-market registry is designed to collect real world data on the use of the Globe PF System for the treatment of atrial fibrillation (AF).",[29],"2026-06-11",{"date":485,"type":34},{"date":573,"type":23},"2026-07",{"date":575,"type":23},"2029-10",{"name":577,"class":41},"Kardium Inc.",{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":585,"enrollmentInfo":586,"targetDuration":4,"studyType":24,"phases":588,"briefSummary":589,"conditions":590,"keywords":592,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":598,"startDateStruct":599,"completionDateStruct":600,"leadSponsor":602,"locationsCount":4},"100612505","castle-hfpef-catheter-ablation-for-atrial-fibrillation-patients-with-heart-failure-with-mildly-reduced-and-preserved-ejection-fraction-100612505","NCT07254455","CASTLE-HFpEF (Catheter Ablation for Atrial Fibrillation Patients With Heart Failure With Mildly Reduced and Preserved Ejection Fraction)","Catheter Ablation Versus Standard Conventional Treatment in Atrial Fibrillation Patients With Heart Failure With Mildly Reduced and Preserved Left Ventricular Ejection Fraction - A Prospective, Randomized, Multi-national Study Using Two Systems for Rhythm Monitoring","Inclusion Criteria:\n\n1. ≥18 years of age at screening visit.\n2. Clinical signs and symptoms of HF (26).\n3. Left ventricular ejection fraction (LVEF) \\>40% within the past 12 months (most recent LVEF measurement)\n4. Elevated NT-proBNP levels during screening or within 12 months prior to screening (most recent value; blood test):\n\n   * For patients in normal sinus rhythm (NSR) at the time of blood sampling: NT proBNP ≥300 pg\u002FmL\n   * For patients in AF at the time of blood sampling: NT-proBNP ≥600 pg\u002FmL\n5. Echocardiographic evidence of HFmrEF\u002FHFpEF, with at least one of the following during screening or within the 12 months prior to screening:\n\n   1. Left atrial volume index (LAVI) ≥34 mL\u002Fm2 for patients in NSR, or LAVI ≥40 mL\u002Fm2 for patients in AF.\n   2. Tricuspid regurgitation (TR) peak velocity \\>2.8 m\u002Fs.\n   3. Mitral E\u002Fe' ratio at rest ≥9.\n   4. Left ventricular mass index (LVMI) ≥115 g\u002Fm2 for men and ≥95 g\u002Fm2 for women.\n   5. Septal thickness or posterior wall thickness ≥1.1 cm.\n6. Patients previously diagnosed with persistent AF since ≤4 months prior to screening with an indication for anticoagulation, OR Patients previously diagnosed with paroxysmal AF since ≤4 months prior to screening with an already known AF burden of ≥1% and\u002For an AF episode of ≥24 hours, with an indication for anticoagulation OR Patients with paroxysmal AF without known AF burden (diagnosed since ≤4 months prior to screening) or no previously diagnosed AF who are subsequently diagnosed with AF after receiving a single-lead electrocardiography (ECG) patch for 30 days. These patients should have an AF burden of ≥1% and\u002For an AF episode of ≥24 hours on the ECG patch (more details down below in section 8.1.1) and an indication for anticoagulation.\n7. Stable optimal medical therapy for HFmrEF\u002FHFpEF for at least 4 weeks (diuretics \\& SGLT2 inhibitors unless contraindicated; angiotensin receptor-neprilysin inhibitors \\& mineralocorticoid receptor antagonists as deemed appropriate by the treating physician; Amiodarone and Beta-blockers are not considered for defining heart failure therapy).\n8. Signed written informed consent obtained from the participant or participant's legal representative and ability for participant to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Participants will be excluded from the study for any of the following reasons:\n\n  1. Previous catheter ablation for AF.\n  2. Known infiltrative cardiomyopathy, hypertrophic cardiomyopathy and amyloidosis.\n  3. Documented left atrial diameter \\>6cm.\n  4. Any contraindication for chronic anticoagulation therapy or heparin, including hypersensitivity to any of the components.\n  5. Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment.\n  6. Planned cardiovascular intervention during the follow-up period.\n  7. Patients with severe valvular disease\n  8. Life expectancy ≤12 months.\n  9. Untreated hypothyroidism or hyperthyroidism (blood test).\n  10. Requirement for dialysis due to end-stage chronic kidney disease.\n  11. Mental or physical inability to participate in the study.\n  12. Women currently pregnant (blood test) or breastfeeding or not using reliable contraceptive measures during fertility age.\n  13. Enrollment in another investigational drug or device study within the last 30 days before registration.\n  14. Medical or psychological conditions that would not permit the participant to complete the study or sign informed consent.\n  15. Known alcohol or drug abuse.\n  16. Presence of a condition, abnormality or disease that in the opinion of the investigator would compromise the safety of the participant or the quality of the data.\n  17. Legal incapacity or limited legal capacity.","120 Years",{"count":587,"type":23},900,[26],"The clinical equipoise in the treatment of Atrial Fibrillation (AF) in patients with Heart Failure with mildly reduced Ejection Fraction\u002FHeart Failure with Preserved Ejection Fraction (HFmrEF\u002FHFpEF) reflects the scarcity of randomized trials on different treatment modalities. By generating high-quality, evidence-based, randomized data on the impact of treatment on hard outcomes, Catheter Ablation Versus Standard Conventional Treatment in Atrial Fibrillation Patients with Heart Failure with Preserved Ejection Fraction (CASTLE-HFpEF) will provide clinical decision-making guidance and help physicians in the management of patients with HFmrEF\u002FHFpEF and AF.\n\nThe main hypothesis is that Catheter Ablation (CA) for AF is associated with improved clinical outcomes in patients with HFmrEF\u002FHFpEF and AF compared to medical AF treatment strategies on top of optimal medical HF treatment. CASTLE-HFpEF aims to study these hard clinical outcomes in a randomized cohort of patients with AF and HFmrEF\u002FHFpEF.",[29,591],"Heart Failure With Preserved Ejection Fraction",[593,594,595,596,597],"A-fib","HFpEF","HFmrEF","AF","Catheter ablation",{"date":553,"type":34},{"date":573,"type":23},{"date":601,"type":23},"2031-10",{"name":603,"class":67},"Tulane University",{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":18,"minAge":611,"maxAge":585,"enrollmentInfo":612,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":613,"conditions":614,"keywords":617,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":489},"100440400","baseline-atrial-fibrosis-predicts-risk-for-post-operative-atrial-fibrillation-in-patients-undergoing-cardiac-surgery-100440400","NCT05014802","Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery","Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery: A Pilot Study for SAPPORO-AF","Inclusion Criteria:\n\n* Male or female patients age 40 years of age or older\n* Patients with no history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) scheduled to undergo cardiac surgery (These surgeries include but are not limited to coronary artery bypass graft (CABG), valvular repair\u002Freconstruction, aneurysm repair, and insertion of pacemaker).\n\nExclusion Criteria:\n\n* Patients with a history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia)\n* Patients with a history of cardiac or open chest surgery\n* Patients with a history of catheter ablation\n* Patients under the age of 40\n* Patients with left ventricular assist device (LVAD) or scheduled to have LVAD implanted\n* Patients who have previously undergone extracorporeal membrane oxygenation (ECMO)\n* Patients who have undergone or will undergo heart transplantation\n* Patients with any health related Late Gadolinium Enhancement (LGE)-MRI contraindications (including previous allergic reaction to gadolinium, pacemakers, defibrillators, other devices\u002Fimplants contraindicated for MRI)\n* Acute or chronic severe renal disease with a low glomerular filtration rate (GFR), \\\u003C30 mL per minute per 1.73 m2 will be excluded from the trial. (A creatinine measurement should be available within the last 6 months. If not, a creatinine blood test will be drawn to assess for renal function before the MRI acquisition).\n* Patients weighing \\> 300 lbs. (MRI image quality decreases due to increased body mass index)\n* Patients currently pregnant or breastfeeding, or plan to become pregnant during the study period\n* Patients with cognitive impairment preventing them from giving informed consent will be excluded from the study\n* Patients who cannot read, speak, and\u002For understand English","40 Years",{"count":22,"type":23},"The study aims to evaluate and compare the incidence of atrial arrhythmias (including Post-Operative Atrial Fibrillation (POAF), atrial flutter, and atrial tachycardia) stratified by baseline Utah fibrosis stages and overall fibrosis (%) of the left atrial wall area. The investigators hypothesize that patients with a higher baseline Utah fibrosis staging will experience a higher incidence of POAF.\n\nThe study also aims to evaluate and compare the in-hospital mortality, length-of-stay (LOS), complication rates (strokes, pneumonia, respiratory failure etc.) of the different Utah fibrosis stage cohorts. Perform cost analysis and compare between patients with POAF and patients without POAF. The investigators hypothesize that patients experiencing POAF will have a higher mortality rate, longer LOS, greater complications, and therefore, additional hospital costs.",[29,473,615,616],"Atrial Flutter","Atrial Tachycardia",[618,619,620],"Atrial Fibrosis","Cardiac Magnetic Resonance Imaging","Cardiac surgery",{"date":553,"type":34},{"date":623,"type":34},"2021-11-21",{"date":625,"type":23},"2026-12",{"name":603,"class":67}]