[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atrial-fibrillation-paroxysmal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atrial-fibrillation-paroxysmal":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,41,71,101,124,155,186,220,248,279,301,326,355,379,398,424,451,476],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100558957","the-effect-of-pulse-field-ablation-on-atrial-mechanics-in-catheter-ablation-of-paroxysmal-atrial-fibrillation-100558957",false,"NCT06557876","The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation","The Effect of Pulse Field Ablation on Atrial Mechanics Assessed by MRI and on Patient-related Outcomes in Catheter Ablation of Paroxysmal Atrial Fibrillation","PF-MRI","Inclusion Criteria:\n\n* Patient age ≥ 18\n* Established diagnosis of paroxysmal fibrillation, with a I\u002FIIa\u002FIIb indication for catheter ablation (ESC 2020 guidelines)\n* Episode of AF documented by ECG within the last 12 months\n* Patient able to give written informed consent\n* If female of childbearing potential, have a negative serum pregnancy test and using effective contraception\n* Be affiliated with a French social security system or entitled\n\nExclusion Criteria:\n\n* Non-paroxysmal atrial fibrillation\n* Contraindication to oral anticoagulation\n* Intracardiac thrombus\n* Previous ablation in the left atrium\n* Previous heart surgery\n* Significant valvular heart disease defined as any moderate (grade 3) or severe (grade 4) mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis, tricuspid regurgitation, or tricuspid stenosis\n* Contraindication to perform MRI or using the DOTAREM™ contrast product (pacemaker, defibrillator, foreign body or prosthesis, old generation heart valves, old generation ferromagnetic vascular surgical clips, percutaneous devices for endocranial aneurysms, neurosimulator, cochlear implants, automated injection device such as insulin pump, and more generally any non-removable electronic device, severe kidney disease with GFR \\\u003C 30 mL\u002Fmin, documented hypersensitivity to gadoteric acid or to excipients, severe claustrophobia)\n* Patient on AME (state medical aid)\n* Pregnant or breast-feeding female\n* Patient protected by law (guardianship, tutelage measure, deprived of liberty)\n* Participation in another interventional study or being in the exclusion period at the end of a previous study.","ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to compare the effect of pulmonary vein isolation on atrial function between pulse-field and cryoablation in patients over the age of 18 with paroxysmal atrial fibrillation. The main question it aims to answer is:\n\n• Is catheter ablation energy (pulse field ablation) revealing a better preservation of the atrial function architecture than with conventional catheter ablation technologies ?\n\nParticipants will performed 2 IRMs with injection and completed Quality of Life Questionnaires. They participate in the study for 4 months.\n\nResearchers will compare 2 arms:\n\n* Pulse-Field Ablation\n* Cryoablation",[27],"Atrial Fibrillation Paroxysmal","RECRUITING","2026-05-29",{"date":31,"type":32},"2026-06-02","ACTUAL",{"date":34,"type":32},"2024-10-09",{"date":36,"type":21},"2026-10-01",{"name":38,"class":39},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":40},"100627875","biofeedback-intervention-for-paroxysmal-atrial-fibrillation-100627875","NCT07454317","Biofeedback Intervention for Paroxysmal Atrial Fibrillation","Remote Physical Activity Biofeedback Intervention for Patients With Paroxysmal Atrial Fibrillation Using Mobile Health Technology.","BI-PAF","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Aged 18 or over.\n* Diagnosed with paroxysmal AF\n* Deemed medically stable and well managed.\n\nExclusion Criteria:\n\n* Any concurrent cardiac arrhythmia\n* Blood pressure \\>180\u002F100\n* Unstable angina\n* Myocardial infarction within the previous 3 months\n* Valvular heart disease\n* Heart failure NYHA class 4\n* \\\u003C6 months post-transplant\n* Resting\u002Funcontrolled tachycardia\n* Stroke in last 6 weeks\n* Cardiac sarcoidosis\n* Injury or disability preventing exercise",{"count":50,"type":21},40,[24],"This project aims to bridge the gap between technology and healthcare by developing a biofeedback intervention that enables daily monitoring of atrial fibrillation episodes and physical activity levels. The main question it aims to answer is:\n\nIs a co-designed, usability-tested, bio-feedback intervention aimed at nudging patients with paroxysmal atrial fibrillation to increase physical activity feasible for a larger randomised control trial?\n\nThe trial is split into two separate phases, each adopting different study designs, data collection, and data analysis methods.\n\nPhase 1 Co-design and usability testing:\n\nIn this phase, we aim to test if smartwatches can be used to monitor AF and physical activity so that personalised atrial fibrillation-specific summaries can be created and sent to participants as text message nudges. The aim is to encourage participants to be more physically active.\n\nParticipants will wear a smartwatch for 3 weeks, during which they will receive text messages giving them feedback on their atrial fibrillation and physical activity. After the 3 weeks, all participants will take part in a workshop to provide feedback on what they thought and what could be improved. Improvements will be implemented by the researchers, and the process will repeat for a total of two iterations. On the first iteration only, participants will also be asked to wear a Holter monitor OR chest strap and an additional smartwatch for the first 24 hours, alongside an accelerometer watch for the first 7 days.\n\nPhase 2 Feasibility study with embedded process evaluation:\n\nThis phase aims to assess whether it is feasible and acceptable to run a larger trial across the UK (i.e. can the intervention be delivered properly and do patients think it is useful).\n\nParticipants will be randomly allocated to either their normal standard of care, or to receive a smartwatch with the biofeedback messaging service in addition to their normal standard of care. The study will take 6 and a half months in total. Both groups will complete online questionnaires periodically over this period. Both groups will also need to wear a smartwatch and accelerometer watch for 7 days before and after testing.",[54],"Atrial Fibrillation (Paroxysmal)",[56,57,58,59,60,61],"Atrial fibrillation","Physical activity","Behavioural economics","Nudge theory","Wrist worn technology","mHealth","2026-05-20",{"date":64,"type":32},"2026-05-22",{"date":66,"type":32},"2026-04-15",{"date":68,"type":21},"2028-02-01",{"name":70,"class":39},"Liverpool John Moores University",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":40},"100594373","ns-pfa-catheter-ablation-of-paroxysmal-atrial-fibrillation-with-the-pulse-biosciences-cellfx-system-100594373","NCT07018596","NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System","Safety and Effectiveness of the CellFX® nsPFA Catheter Endocardial Ablation System for the Treatment of Paroxysmal Atrial Fibrillation","NANOPULSE-AF","Inclusion Criteria:\n\n* A diagnosis of recurrent drug-resistant symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within seven (7) days of onset, documented by the following:\n\n  i. Physician's note indicating the presence of AF symptoms and at least two (2) episodes of self-terminating AF within six (6) months prior to enrollment\n* Age 18 through 85 years old (or older than 18 if required by local law)\n* Failure of at least one AAD (class I or III) for AF as evidenced by recurrence of symptomatic AF, or intolerable side effects due to AAD.\n* Participant is willing and capable of providing Informed Consent\n* Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by study investigators\n\nExclusion Criteria:\n\n* Left atrial diameter ≥5.5 cm (anteroposterior)\n* Any of the following within 3 months prior to enrollment:\n\n  1. Any cardiac surgery\n  2. Myocardial infarction\n  3. Percutaneous Coronary Intervention (PCI) \u002F Percutaneous Coronary Intervention (PTCA) or coronary artery stenting\n  4. Unstable angina\n  5. Pericarditis or symptomatic pericardial effusion\n* Any of the following within 6 months prior to enrollment:\n\n  1. Any cerebral ischemic event (stroke or transient ischemic attack (TIA)\n  2. History of thromboembolic event\n* Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, atrial septal defect (ASD) closure, Left atrial appendage occlusion)\n* Planned Left Atrial Appendage (LAA) closure procedure, Transcatheter Aortic Valve Replacement (TAVR), Mitraclip, Atrial Septal Defect (ASD) or Patent Foramen Ovale (PFO) closure, Triclip or implant of an Implantable Loop Recorder (ILR), permanent pacemaker, biventricular pacemaker, or any implantable cardiac defibrillator (with or without biventricular pacing function) during or for any time during the follow-up period\n* Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure\n* Documented left atrial (LA) thrombus by imaging within 48 hours of the procedure.\n* Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function).\n* Prior diagnosis of pulmonary vein stenosis\n* Valvular cardiac surgical\u002Fpercutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).\n* Moderate to severe mitral valve stenosis\n* More than moderate mitral regurgitation (i.e., 3+ or 4+ MR)\n* New York Heart Association (NYHA) Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measured by acceptable cardiac testing (e.g., TTE)\n* History of pulmonary hypertension with pulmonary systolic artery pressure \\>50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease\n* Rheumatic heart disease\n* Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as warfarin)\n* Active systemic infection\n* Hypertrophic or advanced infiltrative cardiomyopathy\n* Atrial myxoma\n* Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity\n* History of abnormal bleeding and\u002For clotting disorder\n* Renal insufficiency with an estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2, or any history of renal dialysis or renal transplant\n* History of severe chronic gastrointestinal problems involving the esophagus, stomach and\u002For untreated acid reflux\n* Solid organ or hematologic transplant, or currently being evaluated for an organ transplant\n* Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence\n* Other criteria, which the Investigator determines would make the patient unsuitable to participate (e.g. uncontrolled drug and\u002For alcohol addiction, congenital disease, fragility)\n* Body Mass Index (BMI) \\> 40.0\n* Participants with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder)\n* Life expectancy less than one year\n* Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor\n* Unwilling or unable to comply fully with study procedures and follow-up","85 Years",{"count":81,"type":21},215,[24],"The objective of this study is to demonstrate the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Cardiac Catheter Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AF).",[27,85,86],"Cardiac Ablation","Cardiac Arrhythmia",[88,89,90],"nsPFA","Pulsed Field Ablation","nano-PFA","2026-05-03",{"date":93,"type":32},"2026-05-06",{"date":95,"type":32},"2026-04-06",{"date":97,"type":21},"2028-01",{"name":99,"class":100},"Pulse Biosciences, Inc.","INDUSTRY",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100569586","cellfx-nanosecond-pulsed-field-ablation-pfa-360-catheter-ablation-system-for-treatment-of-atrial-fibrillation-100569586","NCT06696170","CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation","Initial Safety and Performance of the CellFX® Nano-PFA 360 Catheter Endocardial Ablation System for the Treatment of Atrial Fibrillation","Inclusion Criteria:\n\n* Subject must be ≥ 18 and ≤ 75 years of age on the day of enrollment\n* Subject is willing and capable of providing Informed Consent to undergo study procedures and participate in all examinations and follow-up visits and tests associated with this clinical study\n* Subjects with PAF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip\n* Subjects who have failed at least one antiarrhythmic drug (AAD; class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as shown by recurrent symptomatic AF, or intolerance to the AAD or AV nodal blocking agents\n* Antero-posterior left atrial diameter ≤ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 3 months prior to the procedure\n* Left ventricular ejection fraction ≥ 40% as documented by TTE within 12 months prior to the procedure\n* Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by the study investigators\n\nExclusion Criteria:\n\n* Subject has an implantable electronic medical device. (i.e., pacemaker, ICD or CRT) or left atrial appendage device\n* Subject has a prosthetic heart valve\n* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause\n* AF episodes lasting \\> 7 days\n* Previous ablation for AF\n* Subjects on amiodarone at any time during the past 3 months prior to enrollment\n* Prior history of pericarditis or pericarditis within 3 months based on the TTE examination\n* Prior history of rheumatic fever\n* Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, atrial septal defect (ASD) closure, left atrial appendage occlusion)\n* History of severe chronic gastrointestinal problems involving the esophagus, stomach and\u002For untreated acid reflux\n* History of abnormal bleeding and\u002For clotting disorder\n* Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as Warfarin)\n* Active malignancy or history of treated cancer within 24 months of enrollment\n* Clinically significant infection or sepsis on the day of index procedure with either fever, leukocytosis or requiring intravenous antibiotics\n* History of stroke or TIA within prior 6 months, or any prior intracranial hemorrhage or permanent neurological deficit\n* New York Heart Association (NYHA) class IIIb or IV congestive heart failure and\u002For any heart failure hospitalization within 3 months prior to enrollment\n* Body mass index \\> 35 kg\u002Fm2\n* Estimate glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m2 or has ever received hemodialysis\n* History of untreated and serious hypotension, bradycardia or chronotropic incompetence\n* Any of the following within 3 months of enrollment:\n\n  1. Major surgery except for the index procedure\n  2. Myocardial infarction\n  3. Unstable angina\n  4. Percutaneous coronary intervention\n  5. Sudden cardiac death event\n  6. Left atrial thrombus that has not resolved as shown by TEE or CT\n* Solid organ or hematologic transplant, or currently being evaluated for an organ transplant\n* History of pulmonary hypertension with pulmonary systolic artery pressure \\>50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease\n* Subjects with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder)\n* Life expectancy less than one year\n* Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.\n* Females of childbearing potential who are nursing, pregnant, or planning to become pregnant during the study period\n* Other criteria, which the Investigator determines would make the patient unsuitable to participate (e.g. uncontrolled drug and\u002For alcohol addiction, congenital disease, fragility)","75 Years",{"count":110,"type":21},60,[24],"The objective of this study is to demonstrate initial safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA or nano-PFA) 360 Catheter Endocardial Ablation System in treating subjects with atrial fibrillation.",[27,85,86],[88,115,89,90],"CellFX",{"date":117,"type":32},"2026-05-05",{"date":119,"type":32},"2024-07-25",{"date":121,"type":21},"2026-07-25",{"name":99,"class":100},3,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":40},"100634565","safety-and-efficacy-of-conscious-sedation-versus-general-anesthesia-in-pulsed-field-ablation-for-paroxysmal-atrial-fibrillation-100634565","NCT07541339","Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation","Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation: A Randomized Controlled Trial","SEDATE-PFA","Inclusion Criteria:\n\n* Aged 18 to 80 years\n* Diagnosed with paroxysmal atrial fibrillation\n* No prior history of catheter ablation for atrial fibrillation\u002Fatrial flutter\n* Scheduled to undergo pulsed-field ablation\n* Provide written informed consent for study participation and be able to complete all scheduled follow-up assessments\n\nExclusion Criteria:\n\n* Obstructive sleep apnea-hypopnea syndrome (OSAHS)\n* Complicated with severe chronic obstructive pulmonary disease (COPD), asthma or other respiratory system diseases\n* Body mass index (BMI) \\>30 kg\u002Fm² or \\\u003C20 kg\u002Fm²\n* Preoperative pulse oxygen saturation (SpO₂) \\\u003C93%\n* Anticipated difficult airway\n* Intolerance to general anesthesia (American Society of Anesthesiologists \\[ASA\\] physical status ≥Ⅳ)\n* Current left ventricular ejection fraction (LVEF) ≤40% or New York Heart Association (NYHA) functional class Ⅲ-Ⅳ\n* Acute coronary syndrome within 3 months\n* Within 3 months after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) or other cardiac\u002Fvascular surgeries\n* Moderate\u002Fsevere stenosis or severe regurgitation of aortic or mitral valve\n* Acute cerebrovascular disease within 1 month\n* Severe hepatic insufficiency (Child-Pugh Class C)\n* Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73m² or on dialysis\n* History of chronic heavy alcohol consumption\n* History of substance abuse\n* Hypersensitivity to any medications used in the study protocol\n* Pregnancy or lactation\n* Concurrent participation in other interventional clinical trials\n* Other conditions deemed unsuitable for study participation by the investigators","80 Years",{"count":134,"type":21},224,[24],"The goal of this clinical trial is to compare the safety and efficacy of conscious sedation and general anesthesia in patients with paroxysmal atrial fibrillation undergoing their first pulsed-field ablation (PFA) procedure. It will also establish a scalable conscious sedation protocol for PFA. The main questions it aims to answer are:\n\n1. Does conscious sedation reduce the incidence of the composite safety endpoint (persistent hypotension or hypoxemia for more than 60 seconds intraoperatively) compared with general anesthesia?\n2. What are the differences in perioperative indicators and adverse events between the two anesthetic strategies in PFA for paroxysmal atrial fibrillation? Researchers will randomly assign eligible patients to a conscious sedation group or a general anesthesia group at a 1:1 ratio to compare the safety and efficacy of the two anesthetic approaches.\n\nParticipants will:\n\n1. Receive the assigned anesthetic strategy combined with standardized PFA procedure\n2. Complete intraoperative vital sign and related index monitoring\n3. Undergo follow-up visits at 12-24 hours, 30 days and 90 days after surgery for relevant index assessment and adverse event recording",[54],[139,140,141,142,143,144],"Paroxysmal atrial fibrillation","Pulsed-field ablation","Conscious sedation","General anesthesia","Efficacy","Safety","NOT_YET_RECRUITING","2026-04-14",{"date":148,"type":32},"2026-04-21",{"date":150,"type":21},"2026-04-01",{"date":152,"type":21},"2027-03-01",{"name":154,"class":39},"Beijing Anzhen Hospital",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":163,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":173,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":40},"100617911","preactive-preconditioning-exercise-intervention-to-improve-symptoms-and-quality-of-life-in-comorbid-atrial-fibrillation-and-hfpef-100617911","NCT07324772","PREACTIVE: Preconditioning Exercise Intervention to Improve Symptoms and Quality of Life in Comorbid Atrial Fibrillation and HFpEF","PREACTIVE: Preconditioning With REsistance and AerobiC Training to ImproVe Exercise Intolerance and Quality of Life in Comorbid Atrial Fibrillation and HFpEF","PREACTIVE","Inclusion Criteria:\n\nAll participants will be age 60 and older, have a primary diagnosis of AF and HFpEF, based on electronic health record review. Patients with persistent AF or Paroxysmal AF are eligible. HFpEF will be defined in accordance to the 2022 AHA\u002FACC\u002FHFSA Guideline using a clinical composite score, the H2FPEF score, in conjunction with diagnostic criteria below:\n\n* Ejection fraction ≥ 50%\n* E\u002Fe' ≥15 by Doppler Echocardiography\n* High H2FpEF score (≥5)\n* Must be in stable medical condition and able to begin an exercise program\n\nExclusion Criteria:\n\n* Valvular heart disease as the primary etiology of heart failure (i.e., severe aortic stenosis or mitral regurgitation),\n* New York Heart Association Stage IV\n* Recent stroke (\\\u003C1 year)\n* Evidence or History of Cardiac amyloidosis\n* Patients with persistent AF and poor rate control (HR \\> 110 at rest)\n* Significant change in cardiac medication or Heart Failure symptoms \\\u003C 2 weeks\n* Unstable or severe angina not controlled during daily activity by pharmacological therapy or at \\\u003C4 METS activity\n* Uncontrolled hypertension (defined as systolic blood pressure \\>200 mm Hg and\u002For diastolic blood pressure\\>110 mm Hg) with medications\n* Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions\n* Hospitalization or urgent care visit \\\u003C 4 weeks\n* Oxygen dependent Chronic Obstructive Pulmonary Disease (COPD)\n* Significant anemia (\\\u003C10 g\u002FdL Hgb)\n* End stage renal replacement therapy associated with the need for dialysis\n* Active treatment for cancer defined as current radiation, chemotherapy, immunotherapy, or cancer recurrence within past 5 years\n* Hospice care and indication of life expectancy less than 2 years\n* Complete dependence confinement to a Wheelchair confinement or requiring a visual impairment or Orthopedic or severe musculoskeletal conditions that would prohibit resistance training or aerobic exercise.\n* Physician diagnosed Alzheimer's disease or Dementia or bipolar or psychotic disorder; Montreal Cognitive Assessment (MoCA) is ≤ 18 (based on participant screening)\n* High levels of physical functioning based the composite short physical performance battery score of ≥10 (out of 12)\n* Planned major surgery, coronary or leg revascularization during the next six months\n* Participation in a supervised exercise program or already engaging in regular exercise\n* Plans to transfer care outside of NU within the study period\n* Unable to consent or commit to requires study procedures\n* Non-English speaking","60 Years","99 Years",{"count":166,"type":21},30,[24],"Atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF) are very common conditions that often occur together and result in worsening symptoms and reduced quality of life (QoL). Limitations being able to participate in activities of daily living is a primary complaint for AF-HFpEF patients, yet effective strategies to address this issue remain limited. While exercise interventions targeting aerobic training (AT) are recommended for patients with AF and HFpEF, unique challenges exist in this patient population who tend to be older. Specifically, many older patients with AF and HFpEF have muscle weakness, sarcopenia and frailty, that can make aerobic-focused exercise difficult and less tolerable. This study proposes that starting with progressive resistance training (PRT) before aerobic exercise may overcome these issues by improving muscle strength, making AT more manageable, and leading to better health outcomes. The goal of this study is to assess whether a sequential exercise program, named 'PREACTIVE' improves how people feel, decrease the amount of symptoms, and their ability to participate in exercise and activities.\n\nThis study will specifically test a sequenced exercise approach of resistance training followed by aerobic exercise to improve symptoms, and quality of life in AF-HFpEF.",[170,54,171,172],"Atrial Fibrillation (AF)","Persistent Atrial Fibrillation","Heart Failure With Preserved Ejection Fraction (HFPEF)",[174,175,176,177],"exercise","exercise capacity","symptom severity","quality of life",{"date":179,"type":32},"2026-04-08",{"date":181,"type":21},"2026-04-13",{"date":183,"type":21},"2027-05",{"name":185,"class":39},"Northwestern University",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":203,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":4},"100629048","alps-single-chamber-new-device-study-100629048","NCT07469579","ALPs Single ChambEr New Device Study","Early Feasibility Study of the Single Chamber ALPS Leadless Pacemaker System in Patients With Bradycardia","ASCEND","Inclusion Criteria:\n\n1. Male or female, ≥ 18 years of age at enrolment\n2. Subject who has a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC\u002FAHA\u002FHRS\u002FEHRA guidelines:\n\n   1. Paroxysmal or permanent high-grade AV block in the presence of Atrial Fibrillation (AF)\n   2. Paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when dual chamber transvenous pacing system is considered difficult, elevated risk, or not deemed necessary for effective therapy.\n   3. Symptomatic bradycardia-tachycardia syndrome or Sinus Node Dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when dual chamber transvenous pacing system is considered difficult, elevated risk, or not deemed necessary for effective therapy.\n3. Subject able and willing to undergo the study requirements and is expected to be geographically stable for the duration of the follow-up.\n4. Subject with a life expectancy of more than 24 months.\n5. Subject is able and willing to use the Home Monitor.\n6. Written informed consent to participate in the study obtained from the subject, according to local regulations, prior to initiation of any study mandated procedure.\n\nExclusion Criteria:\n\n1. Subject who is entirely pacemaker dependent (escape rhythm \\\u003C30 bpm).\n2. Subject has an existing or prior pacemaker, ICD, or CRT device implant.\n3. Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.\n4. Subject had recent cardiovascular or peripheral vascular surgery within 30 days prior to enrollment\n5. Subject with current implantation of a neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.\n6. Subject with a prior intervention of the tricuspid valve, implanted vena cava filter that cannot be crossed, or left ventricular assist device (LVAD).\n7. Subject who is morbidly obese (BMI \\> 40).\n8. Subject who has a below normal BMI (BMI\\\u003C18).\n9. Subject whose femoral venous anatomy is unable to accommodate a 24 French introducer sheath or an implant on the right side of the heart (for example, due to obstructions or severe tortuosity) in the opinion of the implanter.\n10. Subject with ventricular dysfunction and LVEF ≤ 50\n11. Subject who is considered as unable to tolerate an urgent sternotomy.\n12. Subject with a known intolerance to Titanium, titanium nitride, parylene C, PEEK, platinum-iridium alloy, heparin, or sensitivity to contrast media.\n13. Subject for whom a single dose of 1.0 mg dexamethasone acetate may be contraindicated.\n14. Subject with a life expectancy of less than 24 months.\n15. Subject with significant co-morbid conditions or other conditions which, at the discretion of the PI, are deemed to prohibit study entry\n16. Subject who is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Cairdac study manager.\n17. Pregnant woman, or woman of childbearing potential and who is not on a reliable form of birth control.\n18. Subject with exclusion criteria required by local law (e.g. age, breast feeding, etc.).",{"count":195,"type":21},15,[24],"Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.",[199,200,201,202,54],"Brady-tachy Syndrome","Brady Arrythmia","Bradycardia","AV Block",[204,205,206,207,208,209,210],"leadless pacemaker","leadless cardiac pacemaker","bradycardia","brady-tachy syndrome","AV block","Atrial Fibrilation","leadless pacing system","2026-03-16",{"date":213,"type":32},"2026-03-18",{"date":215,"type":21},"2026-06",{"date":217,"type":21},"2028-12",{"name":219,"class":39},"Cairdac SA",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":40},"100617695","the-effect-of-a-digital-mediyoga-program-on-quality-of-life-blood-pressure-and-heart-rate-among-patients-with-atrial-fibrillation-100617695","NCT07321964","The Effect of a Digital MediYoga Program on Quality of Life, Blood Pressure and Heart Rate Among Patients With Atrial Fibrillation","The Effect of MediYoga on Quality of Life, Blood Pressure and Heart Rate Among Patients With Atrial Fibrillation: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 18 and above\n* Diagnosed with paroxysmal atrial fibrillation\n* EHRA score at 2 or more\n* Owner of a smartphone or tablet\n* Speaking and reading Danish\n* No comorbidity that restricts them from participating in the intervention\n\nExclusion Criteria:\n\n* Elevated TSH Hormone\n* Participated in mindfulness or yoga exercise regularly at any point during the last two years.",{"count":228,"type":21},456,[24],"Atrial fibrillation (AF) is the most common cardiac arrythmia, associated with increased risk of stroke, heart failure, reduced quality of life (QoL), and psychological distress. This randomized controlled trial investigates the effect of MediYoga - a program incorporating deep breathing, low-intensity yoga, and meditation- on disease-specific QoL, blood pressure, and heart rate in 456 patients with paroxysmal AF. With a strong focus on sustainability, the study is fully digital: participants are recruited online, and the 12-week intervention is delivered through an application to smartphone. Additionally, the participants receive online support via Teams. Data will be collected at baseline, 3, 6, and 12 months. The primary outcome is disease specific QoL; secondary outcomes include blood pressure, heart rate, generic QoL, and psychological wellbeing.\n\nQualitative interviews will explore patients' experiences with the intervention.",[170,54,232,233],"Quality of Life","Mental Health",[235,236,237,232,238],"Digital Health Intervention","Atrial Fibrillation","Yoga","Nursing","2026-01-05",{"date":241,"type":32},"2026-01-07",{"date":243,"type":32},"2025-09-01",{"date":245,"type":21},"2028-09-01",{"name":247,"class":39},"Herlev and Gentofte Hospital",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":256,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":278},"100574045","full-avoidance-vs-permissiveregulated-drinking--outcomes-on-fibrillation-100574045","NCT06754176","Full-Avoidance vs. Permissive\u002FRegulated Drinking & Outcomes On Fibrillation","Full-Avoidance vs. Permissive\u002FRegulated Drinking & Outcomes On Fibrillation (FULL-PROOF)","FULL-PROOF","Inclusion Criteria\n\n* Comfortable reading and writing in English\n* Have a smartphone and willing and able to use the Eureka mobile application\n* Currently diagnosed with paroxysmal AFib without a plan to change their AFib management during the two-week monitoring period\n* At least one episode of AFib in the past month OR, in the judgement of a healthcare provider, could potentially have one episode of AF in the next month\n* Drank alcohol at least 1 day\u002Fweek on average in the past month\n* Willing and able to be randomly assigned daily to avoid or not avoid drinking alcohol over a 2-week period\n* Willing and able to provide written informed consent\n\nExclusion Criteria\n\n* Only post-operative AFib\n* Greater than 40% ventricular pacing\n* History of alcohol addiction or abuse determined by self-reported history or AUDIT-C score\n* Intolerance to alcohol\n* History of liver disease\n* Currently incarcerated\n* Currently pregnant or trying to get pregnant","21 Years",{"count":258,"type":21},100,[24],"The goal of this study is to assess the short-term effects of minimal and moderate drinking on atrial fibrillation (AFib) episodes in a real-world population diagnosed with 'come-and-go'\u002Fparoxysmal AFib. The question it aims to answer is:\n\nIs there a greater occurrence of AFib episodes when participants are allowed to consume alcohol according to random assignment?\n\nParticipants will:\n\n* Be given daily random assignments to avoid or not to avoid alcohol\n* Wear an adhesive electrocardiographic (ECG) heart monitor\n* Wear a wrist-worn fitness tracker\n* Wear an anklet transdermal alcohol monitor\n* Wear an adhesive glucose monitor\n* Complete morning and evening surveys daily\n\nParticipants may be compensated up to $50 for full completion of the study. This study can be done in-person or remote.",[170,54],[263,264,265,236,266,267,268],"Alcohol","Drinking","Mediterranean Drinking Pattern","AFib","AF","Heart Rhythm","2025-12-19",{"date":271,"type":32},"2025-12-23",{"date":273,"type":32},"2025-04-17",{"date":275,"type":21},"2029-08",{"name":277,"class":39},"University of California, San Francisco",2,{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":22,"phases":287,"briefSummary":288,"conditions":289,"keywords":290,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":40},"100546284","esophageal-temperature-during-pvi-using-q-dot-micro-100546284","NCT06392932","Esophageal Temperature During PVI Using Q-DOT Micro","Esophageal Temperature Dynamics and Injury During Pulmonary Vein Isolation With Temperature Controlled Very-High-Power Short-Duration Lesions Using the Novel Q-DOT Micro Ablation Catheter","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged greater than or equal to 18 years\n4. Diagnosed with paroxysmal atrial fibrillation\n5. Undergoing RF catheter ablation for treatment of paroxysmal atrial fibrillation that will involve circumferential point-by-point radiofrequency ablation pulmonary vein isolation with no additional left atrial posterior wall ablation planned\n\nExclusion Criteria:\n\n1. Patients who have undergone prior left atrial ablation procedures.\n2. Patients where the use of the Q-DOT Micro ablation catheter in QMODE+ (i.e. temperature-controlled very-high-power short-duration ablation) is felt to be unsafe.\n3. Patients who have contraindications to capsule endoscopy, or GI conditions that may increase the risks of capsule endoscopy (e.g. esophageal strictures, inflammatory bowel disease, etc)\n4. Any records flagged \"break the glass\" or \"research opt out.\"",{"count":166,"type":21},[24],"This study will assess how two different ablation strategies, using two different ablation catheters during catheter ablation for paroxysmal atrial fibrillation, affect the temperature of the esophagus during ablation, and the risk of injury to the esophagus.",[27],[236,291],"Esophageal thermal injury","2025-10-26",{"date":294,"type":32},"2025-10-28",{"date":296,"type":32},"2024-10-04",{"date":298,"type":21},"2027-03",{"name":300,"class":39},"Cedars-Sinai Medical Center",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":314,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":40},"100579795","pulmonary-vein-isolation-with-the-single-shot-endoscopic-ultra-compliant-pfa-balloon-for-the-treatment-of-af-100579795","NCT06828939","Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF","Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation","VISION AF","Inclusion Criteria:\n\n* Recurrent symptomatic PAF with at least one documented episode\n* Failure or intolerance of at least one AAD\n* Age 18-75 years\n* Patient is indicated for an ablation procedure according to society guidelines or study site practice\n* Patient is willing and able to give informed consent\u002Fparticipate in baseline and follow-up assessments for the duration of the study\n\nExclusion Criteria:\n\n* overall good health as established by multiple criteria",{"count":310,"type":21},75,[24],"This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal (short-duration) AF who have not had a previous catheter ablation for AF will be considered for the study. Patients will be followed for one year after the initial ablation procedure.",[54],[315,316],"ablation","pulsed field ablation","2025-10-02",{"date":319,"type":32},"2025-10-07",{"date":321,"type":32},"2024-12-12",{"date":323,"type":21},"2026-05-31",{"name":325,"class":100},"CardioFocus",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":337,"conditions":338,"keywords":342,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":40},"100409069","value-of-screening-and-treatment-of-sahs-in-the-management-of-af-ablation-candidates-100409069","NCT04606693","Value of Screening and Treatment of SAHS in the Management of AF Ablation Candidates","Value of Screening and Treatment of Sleep Apnea-Hypopnea Syndrome in the Management of Atrial Fibrillation Ablation Candidates","SLEEP-AF","Inclusion Criteria:\n\n* Patients with paroxysmal or persistent atrial fibrillation\n* Recurrent atrial fibrillation despite treatment with at least one class I or III antiarrhythmic\n* No previous diagnosis of apnea-hypopnea syndrome\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years\n* Pregnant women\n* Doubts about the patient's ability to perform a home respiratory polygraphy\n* Doubts about the patient's ability to acquire rhythm records with the Kardia system (smartphone required)\n* Unavailability for follow-up at our center for at least 1 year.",{"count":335,"type":21},50,[24],"The present prospective cohort study (not randomized) analyses the value of screening and treatment of SAHS in the management of patients with AF refractory to antiarrhythmics drugs, potentially candidates for ablation.\n\nPatients at low risk of suffering from SAHS will follow conventional management of their AF, according to the usual criteria of the Arrhythmia Unit. Patients with high or intermediate risk of SAHS, will undergo respiratory polygraphy. If the result is positive, they will be treated as standard for this syndrome and their heart rate will be monitored for 3 months. After this, the patient's arrhythmic load will be reevaluated differentiating patients into two groups, those that must be ablated from those that have improved their condition and the clinical criteria is no longer ablation but follow-up.",[27,339,340,341],"Atrial Fibrillation, Persistent","Apnea Syndrome","Hypopnea Syndrome",[236,343,344,345],"Apnea","Hypopnea","SAHS","2025-09-09",{"date":348,"type":32},"2025-09-15",{"date":350,"type":32},"2020-11-05",{"date":352,"type":21},"2026-12-31",{"name":354,"class":39},"Hospital San Carlos, Madrid",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":366,"conditions":367,"keywords":368,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":40},"100606124","pulsed-field-ablation-with-concomitant-radiofrequency-cardioneuroablation-in-patients-with-paroxysmal-atrial-fibrillation-100606124","NCT07171463","Pulsed Field Ablation With Concomitant Radiofrequency Cardioneuroablation in Patients With Paroxysmal Atrial Fibrillation","Evaluation of the Safety and Efficacy of Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation Using Point-by-Point Bipolar Pulsed Field Ablation Combined With Thermal Ablation of the Superior Paraseptal Parasympathetic Ganglion Region","PFACNA-AF","Inclusion Criteria:\n\n* Age ≥18 years\n* Documented paroxysmal atrial fibrillation (AF) lasting ≥30 seconds on ECG or Holter monitoring\n* Willingness and ability to provide written informed consent\n* Life expectancy \\>1 year\n\nExclusion Criteria:\n\n* Persistent AF lasting \\>7 days or long-standing AF \\>1 year\n* Secondary AF due to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-cardiac causes\n* Left atrial anteroposterior diameter ≥45 mm on transthoracic echocardiography\n* Clinically significant coexisting arrhythmias other than AF\n* Significant valvular heart disease or valve prosthesis\n* Chronic heart failure NYHA class III\u002FIV\n* Previous AF or atrial flutter ablation\n* Prior closure of atrial septal defect or left atrial appendage\n* Atrial myxoma\n* Implanted pacemaker or defibrillator\n* History of pericarditis\n* Congenital heart disease\n* Coagulopathy or bleeding disorders\n* Contraindications to oral anticoagulation\n* Contraindications to CT or MRI\n* Pregnancy or breastfeeding\n* Body Mass Index \\>30\n* History of organ transplantation\n* Severe pulmonary disease\n* Estimated Glomerular Filtration Rate \\\u003C30 mL\u002Fmin\u002F1.73 m²\n* Active malignancy\n* Significant infection\n* Life expectancy \\\u003C1 year\n* Psychiatric disorders preventing study participation\n* Refusal or inability to provide informed consent",{"count":364,"type":21},20,[24],"Pulsed-field ablation (PFA) is a novel, non-thermal method for the treatment of atrial fibrillation (AF). It uses short, high-voltage electrical pulses to selectively ablate cardiomyocytes. PFA has demonstrated a high safety profile with reduced complication rates compared to thermal ablation.\n\nThermal ablation of parasympathetic ganglia during conventional pulmonary vein isolation (PVI) may improve long-term procedural outcomes by reducing AF recurrence. However, due to its non-thermal nature, PFA may not significantly affect cardiac autonomic innervation, which could be clinically relevant in vagally mediated AF or tachycardia-bradycardia syndrome.\n\nThis randomized study compares two strategies: (1) PFA-only PVI, and (2) PFA combined with selective thermal ablation (radiofrequency energy) of the superior paraseptal parasympathetic ganglion. The primary objective is to evaluate whether adjunctive thermal ablation improves clinical outcomes and reduces intraprocedural bradyarrhythmic events.",[54],[56,89,369],"Cardioneuroablation","2025-09-07",{"date":372,"type":32},"2025-09-12",{"date":374,"type":32},"2025-05-26",{"date":376,"type":21},"2026-09-30",{"name":378,"class":39},"St. Joseph's Centre, Poland",{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":4},"100605444","a-study-evaluating-the-effectiveness-and-safety-of-pulsed-field-ablation-using-the-farapulse-system-for-electrical-isolation-of-pulmonary-veins-and-superior-vena-cava-100605444","NCT07162597","A Study Evaluating the Effectiveness and Safety of Pulsed Field Ablation Using the FARAPULSE™ System for Electrical Isolation of Pulmonary Veins and Superior Vena Cava","Inclusion Criteria:\n\n* Age between 18 and 75 years.\n* Documented diagnosis of paroxysmal atrial fibrillation (PAF), defined as typical AF electrographic characteristics (absence of P waves with irregular fibrillatory waves) recorded on 12-lead ECG or symptomatic Holter monitoring, with each episode lasting less than 7 days.\n* Symptomatic despite attempted antiarrhythmic drug therapy.\n* Scheduled to undergo initial catheter ablation procedure.\n* Voluntarily provided written informed consent.\n\nExclusion Criteria:\n\n* AF secondary to electrolyte imbalance, thyroid disorders, or other reversible\u002Fnon-cardiac causes.\n* Persistent atrial fibrillation.\n* Presence of persistent left superior vena cava.\n* Contraindications to pulsed field ablation (e.g., left atrial appendage thrombus, post-atrial septal defect device closure, permanent metallic implants in the left atrium) or contraindications to anticoagulant therapy.\n* Unsuitable for deep sedation\u002Fanesthesia per operator assessment.\n* Life expectancy less than 1 year.\n* Other conditions deemed inappropriate for inclusion by the investigator.",{"count":386,"type":21},200,[24],"This study is a prospective, single-center, single-arm clinical trial planning to screen and enroll 200 subjects. It aims to evaluate the efficacy and safety of pulsed field ablation (PFA) using the FARAPULSE™ system for pulmonary vein isolation (PVI) and superior vena cava isolation (SVCI) in Chinese patients with paroxysmal atrial fibrillation (PAF). Baseline preoperative data, along with intraoperative and postoperative follow-up information, will be collected. The primary endpoint is the proportion of subjects achieving successful PVI and SVCI using solely the FARAPULSE™ PFA system. Secondary endpoints include long-term procedural success rates and various procedural parameters. Additionally, the incidence of adverse events will be recorded as safety endpoints. The study adopts a single-arm target value design hypothesis, and research data will also be compared with historical data from patients treated with radiofrequency ablation for PVI and SVCI to further evaluate the efficacy of PFA. Subgroup analysis will be conducted in patients with heart failure to assess the efficacy and safety of PFA in this population.",[54],"2025-09-06",{"date":346,"type":32},{"date":393,"type":21},"2025-10-01",{"date":395,"type":21},"2028-06-30",{"name":397,"class":39},"Shanghai Zhongshan Hospital",{"id":399,"slug":400,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":406,"targetDuration":4,"studyType":22,"phases":407,"briefSummary":409,"conditions":410,"keywords":412,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":123},"100481495","phase-3-flecainide-versus-amiodarone-in-the-cardioversion-of-paroxysmal-atrial-fibrillation-at-the-emergency-department-in-patients-with-coronary-artery-disease-without-residual-ischemia-100481495","NCT05549752","Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia","Safety and Efficacy of Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia and Ejection Fraction > 35%","FLECA-ED","Inclusion Criteria:\n\n1. Age: 18-85 years old\n2. Paroxysmal Atrial Fibrillation, documented by 12-lead ECG, with one of the following:\n\n   1. Atrial Fibrillation onset less than 48 hours from the time of presentation to the Emergency Department\n   2. Atrial Fibrillation onset between 48 hours and 7 days from the time of presentation to the Emergency Department, and patient has been on anticoagulation for at least 30 days\n   3. History of Coronary Artery Disease without residual ischemia, defined by one of the following criteria:\n\n      * PCI \\\u003C= 1 year, or\n      * CABG \\\u003C= 3 years, or\n      * Negative imaging-based stress testing within 1 year, and:\n\n        * History of known coronary artery stenosis \\> 60% without revascularization, or\n        * PCI \\>= 1 year, or\n        * CABG \\>= 3 years\n3. Ejection Fraction \\> 35% (documented by cardiac ultrasound at the Emergency Department, or within 1 year)\n4. Signed informed consent from the patient or legal representative.\n\nExclusion Criteria:\n\n1. Based on ECG at the Emergency Department:\n\n   1. Atrial Flutter\n   2. Newly documented Left Bundle Branch Block (LBBB)\n   3. Newly documented Right Bundle Branch Block (RBBB) with QRS duration \\> 150ms\n2. Previously documented 24-hour ECG holter monitoring with \\> 720 poly PVCs\u002F24hours, or non sustained ventricular tachycardia\n3. No history of coronary artery disease\n4. ST-Segment Elevation Myocardial Infarction (STEMI)\n5. Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), according to ESC 2020 guidelines on NSTEMI:\n\n   1. If troponin at t0h is over the \"low\" criterion on table of the cutoff values\n   2. If the change of troponin (Δtroponin) at t1h is over the respective cutoff value at the table for the cutoff values\n6. Unstable angina, defined as myocardial ischemia at rest or at minimum effort, in the absence of acute injury\u002Fnecrosis of myocardial cells\n7. Known residual ischemia:\n\n   1. Positive imaging-based stress testing\n   2. Negative imaging-based stress testing \\>= 1 year, and:\n\n      * History of known coronary artery stenosis \\> 60% without revascularization, or\n      * PCI \\>= 1 year, or\n      * CABG \\>= 3 years\n8. History of acute coronary syndrome within 1 year\n9. Severe Aortic Valve Stenosis (mean pressure gradient \\> 40mmHg, AVA \\\u003C 1cm\u002Fm\\^2)\n10. Severe Chronic Kidney Disease (stage \\>= 4)\n11. Severe systematic disease, including neoplasmatic disease under any antineoplasmatic treatment, liver failure, infection with fever\n12. Use of strategy \"pill in the pocket\", by taking flecainide (max 200mg) or propafenone (max 600mg) within 6 hours prior to Emergency Department visit\n13. Known dysanexia or allergy to flecainide or amiodarone\n14. Pregnancy or\u002Fand breastfeeding\n15. Participation in any other clinical trial\n16. Life expectancy less than 1 year\n17. Inappropriate, unfit, or unwilling to follow the desingated protocol procedures.",{"count":20,"type":21},[408],"PHASE3","Current guidelines for the cardioversion of paroxysmal Atrial Fibrillation at the Emergency Department do not prioritize between antiarrhythmic agents and do not consider the time taken for successful cardioversion. Furthermore, the use of flecainide -a class 1C antiarrhythmic agent- is contraindicated for the cardioversion of patients with revascularized coronary artery disease, as well as patients with ischemic cardiomyopathy and preserved ejection fraction. These recommendations stem from insufficient data, mainly from the CAST study.\n\nThe present study is a prospective, multicentre, randomized clinical trial. The primary goals of this clinical trial are to prove the superiority of flecainide over amiodarone in the successful cardioversion of paroxysmal atrial fibrillation at the Emergency Department, and to prove that the safety of flecainide is non-inferior to amiodarone, in patients with coronary artery disease without residual ischemia and ejection fraction over 35%. The secondary goals of the study are to prove the superiority of flecainide over amiodarone in the reduction of hospitalizations from the Emergency Department due to atrial fibrillation, in the time taken to achieve cardioversion, and to the reduction of the need to conduct electrical cardioversion.\n\nThe study population will be all consecutive new-comers to the Emergency Department with primary diagnosis of paroxysmal atrial fibrillation and history of coronary artery disease without angina, without residual ischemia and with ejection fraction \\> 35%. The sample size will be 200 patients, who will be monitored for 30 days. At the Emergency Department, all patients will be under continuous ECG monitoring, and a 24-hour ECG device will also be placed (Holter). The patients will be randomized to the treatment group (flecainide) and the control group (amiodarone).\n\nPatients in both arms will stay at the ED for a total of 6 hours after therapy initiation. If no adverse events occur in this time, the patient will be discharged from the ED. Otherwise, the patient will be admitted to the hospital. At 24 hours, the patients will visit the study centre for physical examination, ECG, cardiac ultrasound, 24-hour ECG removal and adverse events evaluation. At 30 days, follow-up via phone calls will be conducted for the evaluation of the study outcomes and adverse events.\n\nAs of June 2025, an interim analysis has been completed, and preliminary study results have been submitted for presentation at the European Society of Cardiology (ESC) Congress. Based on the interim findings, the study's target sample size has been revised to a total of 80 patients.",[27,411],"Coronary Artery Disease Without Residual Ischemia",[413,414],"Flecainide","Amiodarone","2025-06-10",{"date":417,"type":32},"2025-06-13",{"date":419,"type":32},"2023-03-24",{"date":421,"type":21},"2026-01-30",{"name":423,"class":39},"Hippocration General Hospital",{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":434,"briefSummary":435,"conditions":436,"keywords":437,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":450},"100569739","wide-antral-pulmonary-vein-isolation-in-atrial-fibrillation-ablation-with-a-single-shot-technique-wider-pvi-100569739","NCT06698159","Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)","Wide-Antral Pulmonary Vein Isolation in Patients Undergoing Atrial Fibrillation Ablation with a Single-shot Technique: the WIDER-PVI Trial","WIDER-PVI","Inclusion Criteria:\n\n* Age over 18 years old.\n* Previous diagnosis of paroxysmal or persistent atrial fibrillation less than 2 years after diagnosis.\n* Clinical indication to undergo a pulmonary vein isolation procedure using balloon cryoablation.\n\nExclusion Criteria:\n\n* Severe left atrial dilatation (indexed volume \\>48 ml\u002Fm2 or area \\>40 cm2 or indexed diameter \\>3.0 cm\u002Fm2).\n* Previous endocardial or surgical ablation of atrial fibrillation.\n* Severe frailty (Clinical Frailty Scale score 7 or higher) or life expectancy less than 1 year.\n* Inability to understand or give informed consent.\n* Performance of other left atrial ablations in addition to pulmonary veins.\n* Need to use another catheter in addition to the cryoablation catheter to complete pulmonary vein isolation.\n* Contraindication to anticoagulation or intolerance to heparin.\n* Presence of intra-atrial thrombus.\n* Reversible cause of atrial fibrillation.\n* Severe mitral or aortic valve disease.\n* Congenital heart disease.\n* Pregnancy or the prospect of pregnancy in the next 12 months.",{"count":433,"type":21},440,[24],"The WIDER PVI study is a multicentre randomized clinical trial to compare the efficacy of antral versus extended antral PVI in patients with paroxysmal or persistent AF undergoing this procedure using a cryoablation balloon capable of 28 mm diameter (antral isolation) or 31 mm diameter (extended antral isolation) applications. The aim is to evaluate an objective of superiority of the extended antral isolation strategy versus antral isolation in the recurrence of atrial tachyarrhythmias at 1-year follow-up, both in episodes of \\>30 seconds duration and in overall arrhythmic load.",[236,54],[438,439,440],"atrial fibrilation","cryoballoon","cryoablation","2024-11-18",{"date":443,"type":32},"2024-11-20",{"date":445,"type":32},"2024-11-01",{"date":447,"type":21},"2027-06-30",{"name":449,"class":39},"Hospital Universitario 12 de Octubre",17,{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":22,"phases":461,"briefSummary":463,"conditions":464,"keywords":465,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":40},"100461711","phase-2-riluzole-to-reduce-atrial-fib-study-using-holter-monitoring-100461711","NCT05292209","RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring","ASsessment Of RiLuzole To Reduce Paroxysmal Episodes of Atrial FIbrillatiON (The SOLUTION Study)","SOLUTION","Inclusion Criteria:\n\n* Males or Female adult patients (\\> 18 years old) with a history of symptomatic AF documented electrocardiographically within \\> 48 hours to 12 months before enrollment.\n* Is able to provide written informed consent to participate in the study and is able to understand the procedures and study requirements.\n* Must voluntarily sign and date an informed consent form that approved by the University of Utah IRB before the conduct of any study-specific procedure.\n* Will be anti-coagulated or is already anti-coagulated for planned cardioversion.\n* Is planned to undergo a cardioversion.\n* Patients who are not being treated with an anti-arrhythmic agent per their physician's treatment plan\n\nExclusion Criteria:\n\n* Systolic BP \\> 180 mmHg or Diastolic BP \\> 100 mmHg;\n* Atrial Fibrillation due to electrolyte imbalance, hyperthyroidism, pericarditis, or other reversible illness;\n* NYHA FC IV Heart Failure (No ADHF Decompensation with 1 month);\n* Unstable Angina, AMI, coronary surgery within 3 or coronary angioplasty within 1 month of screening;\n* Wolff-Parkinson-White syndrome unless treated with successful ablation;\n* Infiltrative heart disease;\n* Severe valvular heart disease;\n* History of syncope or angina precipitated by an ventricular arrhythmia;\n* History of torsade de pointes;\n* Any polymorphic ventricular tachycardia;\n* Sustained monomorphic ventricular tachycardia, or cardia arrest;\n* Class I or III antiarrhythmic agents;\n* Females of childbearing age. If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile \\[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\\]) or is practicing 1 of the following medically acceptable methods of birth control for at least one full menstrual cycle prior to screening (see below), and agrees to continue with the regimen from the time of screening, throughout the entire study they are excluded;\n* Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 3 full cycles (based on the subject's usual menstrual cycle period) before study medication administration\n* Total abstinence from sexual intercourse since the last menses before study medication administration\n* Intrauterine device\n* Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream);\n* Aminotransferases \\> 5 x ULN (Test in the last 3 months);\n* CYP 1A2 Potent Inhibitors including cimetidine, ciprofloxacin, enoxacin, rifampin, barbiturates, and fluvoxamine; and\n* Active tobacco use. (i.e., smoking)",{"count":460,"type":21},78,[462],"PHASE2","Atrial fibrillation (AF) is a growing clinical problem.1 AF is a highly dynamic condition involving episodes of sinus rhythm interspersed with periods of arrhythmia, becoming more difficult to terminate over time. AF carries a substantial cost, morbidity and mortality burden. There are two important approaches to the management of AF: 1). Controlling ventricular response rate without attempting to terminate or prevent AF (rate control), and 2). Attempting to control and maintain sinus rhythm (rhythm control).2 Current rhythm control with antiarrhythmic agents (AAD) is only moderately beneficial in restoration and maintenance of sinus rhythm but produce serious adverse events. AAD selection is limited based on the potential for pro-arrhythmia, patient's age, presence of structural heart disease, and renal or hepatic dysfunction. All AF anti-arrhythmic agents are associated with harm (number needed to harm 17-119).3 There remains an important need for development of an efficacious safe AAD for the control of AF. Recent published translational studies suggest that that neuronal-type Na+ channel blockade (nNav) with riluzole, a nNav inhibitor used to manage amyotrophic lateral sclerosis (ALS), can effectively suppress triggered atrial arrhythmias.4 In two independent retrospective cohorts, riluzole-treated ALS patients significantly lowered the incidence of new-onset AF. Riluzole is well-tolerated without evidence of pro-arrhythmia.5 Therefore, to assess riluzole's effects on the reduction of paroxysmal episodes of AF, we will conduct a prospective, randomized, placebo-controlled human study using holter monitors that offer continuous electrocardiographic monitoring pre- (1 month) and with exposure to riluzole or placebo (1 month) to determine statistically superior reductions in episodes of AF.",[27],[466],"Atrial Fibrillation Paroxysmal, Riluzole, Holter Monitoring","2023-11-20",{"date":469,"type":32},"2023-11-24",{"date":471,"type":32},"2022-06-15",{"date":473,"type":21},"2024-10-30",{"name":475,"class":39},"University of Utah",{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":485,"briefSummary":486,"conditions":487,"keywords":488,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":4},"100520584","cardioneuroablation-vs-pulmonary-vein-isolation-in-treatment-of-paroxysmal-atrial-fibrillation-100520584","NCT06058468","Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation","Cardioneuroablation of Right Anterior Ganglionated Plexus vs Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation and Enhanced Vagal Tone","Inclusion Criteria:\n\n* Paroxysmal atrial fibrillation documented in ECG or Holter monitoring\n* Deceleration capacity \\>7.5ms\n* Life expectancy more than 1 year\n* Age ≥18 years\n\nExclusion Criteria:\n\n* Permanent AF lasting more than one year or persistent AF lasting more than 7 days\n* AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-heart related causes\n* Anteroposterior dimension of the left atrium in the echocardiography ≥43mm\n* Clinically significant arrhythmias other than AF\n* Significant valvular disease\n* Valve prosthesis\n* Heart failure III or IV Class in New York Heart Association Classification\n* Previous ablation of atrial fibrillation or atrial flutter\n* History of a patent foramen ovale\u002Fatrial septal defect closure\n* History of left atrial appendage closure\n* Atrial myxoma\n* Presence of a cardiac pacemaker, defibrillator or cardiac resynchronization therapy device\n* History of pericarditis\n* Congenital heart disease\n* History of bleeding or coagulation disorders\n* Contraindications to oral anticoagulation\n* Contraindications to computed tomography or magnetic resonance imaging\n* Pregnancy or breast-feeding\n* BMI\\>31\n* History of transplantation\n* Severe lung disease\n* Chronic renal failure defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002Fm2\n* Cancer\n* Significant infection\n* Life expectancy less than one year\n* Mental disorders\n* Lack of informed consent to participate in the trial",{"count":484,"type":21},160,[24],"The goal of this study is to compare effectiveness of cardioneuroablation of right anterior ganglionated plexus and pulmonary vein isolation in patients with enhanced vagal tone expressed as deceleration capacity \\>7.5ms.",[27],[236,489,369],"Vagally-mediated","2023-09-27",{"date":492,"type":32},"2023-09-29",{"date":494,"type":21},"2024-01",{"date":496,"type":21},"2029-06",{"name":378,"class":39}]