[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-valvular-atrial-fibrillation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-valvular-atrial-fibrillation":56},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,72,101,142],{"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":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100614382","applause-study-i---append-system-early-feasibility-study-100614382",false,"NCT07278869","Applause Study I - Append System Early Feasibility Study","Early Feasibility Study of the Append System for Left Atrial Appendage (LAA) Elimination by Invagination and Ligation","Applause","Inclusion Criteria:\n\n1. Male or non-pregnant female aged ≥18 years\n2. Documented non-valvular AF (paroxysmal, persistent, permanent or non-rheumatic valve-related AF)\n3. The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.\n4. The subject is eligible for the defined protocol medication regimen of anticoagulation and antiplatelet therapy following Append procedure.\n5. The patient is deemed appropriate for LAA ligation by the screening committee and the investigator.\n6. The patient has been informed of the nature of the study, agrees to its provisions \\& follow-up evaluations, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).\n\nGeneral Exclusion Criteria:\n\n1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 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. Atrial fibrillation that is defined by a single occurrence or that is considered to be reversible (e.g., due to thyroid disorders, acute alcohol intoxication, trauma, or recent major surgical procedures).\n3. Patients with an indication for chronic oral anticoagulation other than AF (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve)\n4. Clinically significant Severe heart failure (New York Heart Association functional class IV)\n5. Prior cardiac surgery or surgery requiring sternotomy\n6. Recent (within 3 months pre-procedure) stroke or transient ischemic attack.\n7. Recent (within 3 months pre-procedure) myocardial infarction\n8. Recent (within 30 days before the index procedure) or planned (within 60 days after the index procedure) cardiac interventional procedures (e.g., percutaneous coronary intervention, structural heart valve procedures, etc.)\n9. Planned (within 60 days after the index procedure) cardiac surgical procedures or any surgeries which require sternotomy.\n10. Recent (within 30 days before the index procedure) or planned (within 60 days after the index procedure) noncardiac procedures or surgical interventions.\n11. History of symptomatic pericarditis (acute or chronic).\n12. Patient has evidence of cardiac tumor\n13. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2 (by the Modification of Diet in Renal Disease equation), or dialysis at the time of screening\n14. Platelet count \\\u003C50,000 cells\u002Fmm3 or \\>700,000 cells\u002Fmm3, or white blood cell count \\\u003C3,000 cells\u002Fmm3 or known Bleeding diathesis\n15. Active infection with bacteremia\n16. Patient has a known allergy, hypersensitivity or contraindication to aspirin, heparin, or that would preclude any P2Y12 inhibitor therapy, or the patient has contrast sensitivity that cannot be adequately pre-medicated\n17. Current participation in another investigational drug or device study that would interfere with this study\n18. Patient is unable to undergo general anesthesia\n19. Patient has a condition which precludes adequate transesophageal echocardiographic (TEE) or computed tomographic (CT) assessment.\n20. Known other medical illness or known history of substance abuse that may cause non-compliance with the specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years.\n\nCardiac Imaging Exclusion Criteria:\n\n1. Intracardiac thrombus observed during screening\n2. Left ventricular ejection fraction (LVEF) \\\u003C30%\n3. Circumferential pericardial effusion \\>5 mm or signs \u002F symptoms of acute or chronic pericarditis, or evidence of tamponade physiology\n4. Distance from inter-atrial septum fossa ovalis to LAA ostium is less than 40 mm\n5. Any anatomy or prior intervention that would preclude a transseptal approach (including, but not limited to, prior IVC filter placement that cannot be crossed, prior ASD, or prior PFO closure device implantation that precludes transseptal puncture)\n6. LAA structure that in the opinion of the screening committee \u002F investigator precludes intervention","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"NA","This early feasibility study is intended to evaluate the safety and feasibility of the Append System for eliminating the left atrial appendage (LAA) through a transcatheter procedure that invaginates and ligates the LAA tissue.",[27],"Non Valvular Atrial Fibrillation",[29],"Left Atrial Appendage (LAA)","RECRUITING","2026-05-24",{"date":33,"type":34},"2026-05-27","ACTUAL",{"date":36,"type":34},"2026-04-29",{"date":38,"type":21},"2033-03",{"name":40,"class":41},"Append Medical Ltd.","INDUSTRY",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100416368","study-of-the-effects-of-anticoagulant-interruption-covered-by-percutaneous-left-atrial-occlusion-in-patients-with-chronic-atrial-fibrillation-and-radiation-cystitis-at-risk-of-bleeding-100416368","NCT04701749","Study of the Effects of Anticoagulant Interruption Covered by Percutaneous Left Atrial Occlusion in Patients With Chronic Atrial Fibrillation and Radiation Cystitis at Risk of Bleeding","HEMOCC","Inclusion Criteria:\n\n* Patient over 18 years old benefiting a social security sheme.\n* Patient with hematuric radiation bladder associated with a non valvular anticoagulated atrial fibrillation.\n\nExclusion Criteria:\n\n* All the other hematuria's reasons\n* Other reason of anti platelet agent using than atrial fibrillation",{"count":51,"type":21},40,"OBSERVATIONAL","The etiology of the radiation cystitis is a pelvic irradiation generally performed as part of the treatment of prostate cancer. The incidence is 50,000 new cases per year. Approximately 35% of prostate cancer treatment is radiotherapy. The prevalence of haematuric radiation cystitis is 4-5% (about 800 patients).\n\nOne of the complications of radiation cystitis is persistent hematuria. There is currently no curative treatment for this hematuria. There are few treatment options with a random probability of improvement of this symptomatology. These haematurias are rarely resolved spontaneously and most of the time involve emergency room management with +\u002F- invasive procedures, sometimes by hospitalisation, always with a significant psychological impact on the patient.\n\nFurthermore, lifetime anticoagulant treatment considerably increases the likelihood of bladder bleeding. This is the case of patients being followed for Atrial Fibrillation Cardiac Arrhythmia (AFCA), which by definition carries a major cardioembolic risk, and who will be of particular interest in this study.\n\nIn recent years, cardiologists have developed an alternative to anticoagulants: left atrial appendage closure or left atrial occlusion (LAO) . This procedure consists of inserting a nitinol prosthesis in the left atrium, the site of more than 90% of thrombi formation in non-valvular atrial fibrillation. This minimally invasive procedure lasts about 15 minutes and is performed during a 48-hour hospitalization. Anticoagulants are stopped the day after the setting up procedure. Several studies have shown non-inferiority of atrial closure and anticoagulants to thromboembolic events in non-valvular atrial fibrillation. In addition, LAO allows the permanent discontinuation of anticoagulants, associated with the cessation of anticoagulant bleeding adverse events.\n\nWhile studies have been conducted on the impact of this technique on patients monitored in cardiology, no studies evaluate the value of LAO in anticoagulated patients with a hematuric radiation cystitis. This tprocedure is already used in routine care for patients followed in urology, and has shown encouraging results, since 8 out of 10 patients saw a significant reduction in the number of haematurias, but it has never yet been scientifically proven to be effective, hence the aim of this study.\n\nThe interest of this study will therefore be :\n\n* To evaluate the potential benefit of left atrial appendage closure on the number of episodes of hematuria.\n* To evaluate the economic benefit in reducing the number of hospitalizations, surgeries and complications for hematuria as well as the discontinuation of anticoagulants.\n\nAs the patient's data must be retrieved regardless of the patient's subsequent management (with or without a cardiac procedure) within the framework of the HEMOCC protocol, it will be proposed to the patient as soon as he or she is consulting for haematuria on radiation cystitis. The patient will be followed for 3 years.\n\nThe mainly descriptive analyses will be collected in the form of a register and carried out by a biostatistician from Clermont-Ferrand University Hospital.",[55,56],"Radiation Cystitis","Non-valvular Atrial Fibrillation",[58,59,60],"radiation cystitis","Hematuria","Left atrial appendage closure or left atrial occlusion (LAO)","2026-03-18",{"date":63,"type":34},"2026-03-19",{"date":65,"type":34},"2021-02-24",{"date":67,"type":21},"2030-09",{"name":69,"class":70},"University Hospital, Clermont-Ferrand","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100627969","lambre-ii-left-atrial-appendage-occluder-and-occluder-delivery-system-for-patients-with-non-valvular-atrial-fibrillation-100627969","NCT07455539","LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation","A First-in-Man (FIM) Study of the LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation","LAmbre2","Inclusion Criteria:\n\n* The patient age ≥18 years;\n* The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;\n* The patient has a CHA2DS2-VASc score of ≥ 2 in men and CHA2DS2-VASc score of ≥ 3 in women;\n* The patient is recommended for oral anticoagulation therapy, but there is an appropriate rationale for seeking a non-pharmacologic alternative to oral anticoagulation;\n* The patient is deemed suitable for LAA closure by the site investigator and a clinician not a part of the procedural team in the shared decision-making process, and this determination has been documented in the patient's medical record;\n* The patient is willing and able to comply with the required medication post-procedure and follow-up evaluations;\n* The patient (or his or her legally authorized representative) has been informed of the nature of the study, agrees to its provisions, and has been provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).\n\nExclusion Criteria:\n\n* 1\\. Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to the index procedure;\n* Patients with atrial fibrillation that is defined by a single occurrence, or that is transient or reversible (e.g., secondary to CABG, an interventional procedure, pneumonia, or hyperthyroidism);\n* Patients who require long-term anticoagulation for a condition other than atrial fibrillation;\n* Bleeding diathesis or coagulopathy;\n* Patients with rheumatic mitral valve disease, known severe mitral stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis;\n* Active infection with bacteremia;\n* Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, any device material or component (nickel titanium, PET, polypropylene), and\u002For contrast sensitivity;\n* Prior atrial septal defect (ASD) or patient foramen ovale (PFO) surgical repair or implantation of closure device;\n* Left atrial appendage is obliterated and surgical ligated;\n* Underwent any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to the procedure or planned to have the interventional or surgical procedure within 60 days after implant procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, cataract surgery, etc.);\n* Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;\n* New York Heart Association Class IV;\n* Patients with severe renal failure (estimated glomerular filtration rate\\\u003C30 ml\u002Fmin\u002F1.73m2);\n* Known asymptomatic carotid artery disease with\\>70% diameter stenosis OR symptomatic carotid disease (\\>50% diameter stenosis with ipsilateral stroke or TIA). Subjects with prior carotid endarterectomy or carotid stent placement may be enrolled, provided that known diameter stenosis is \\\u003C50%;\n* Life expectancy is less than 1 year;\n* Current participation in another investigational drug or device study.\n\nEchocardiographic Exclusion Criteria:\n\n* Left atrial appendage anatomy cannot accommodate the LAmbre II LAA Occluder per manufacturer IFU;\n* LVEF \\\u003C30%;\n* Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE prior to implant;\n* Presence of a 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 20 bubbles);\n* Existing circumferential pericardial effusion \\>5 mm;\n* Moderate or severe mitral valve stenosis (mitral valve area \\\u003C1.5 cm2);\n* Complex atheroma with mobile plaque of the descending aorta and\u002For aortic arch;\n* Presence of a cardiac tumor",{"count":81,"type":21},10,[24],"Worldwide, atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. The prevalence of AF gradually increases with age; its prevalence is 0.5% \\~ 0.8% among 45 \\~ 59 year-olds, 1.8% \\~ 5.9% among 60 \\~ 69 year-olds, and 6.7% \\~17.9% among \\> 79 year-olds. Thromboembolic complications are the leading cause of death and disability in patients with AF, with ischemic stroke being the most common complication. AF significantly increases the risk of stroke by 3- to 5-fold due to thrombosis caused by abnormal atrial beat. The overall risk of ischemic stroke in patients with AF is 20% \\~ 30%, and strokes due to atrial fibrillation account for 20% of all strokes.\n\nIn the current 2023 ACC\u002FAHA\u002FACCP\u002FHRS Guideline, percutaneous LAAC has been classified as a Class 2a indication for stroke prevention in patients with AF, a moderate to high risk of stroke, and a contraindication to long-term oral anticoagulation due to a nonreversible cause. However, the implantation procedure does have adverse effects which include serious pericardial effusion, procedure-related ischemic stroke, and device embolization. Due to the anatomical diversity of the LAA, certain patients are not candidates for this device.\n\nThe LAmbre™ Left Atrial Appendage Closure System, manufactured by Lifetech Scientific (Shenzhen) Co.Ltd., is the first generation of LAmbre LAAO device which is CE-marked and is current approved in Hong Kong Hospital Authority for regular clinical use. It consists of a LAA Occluder and a Delivery System and is a percutaneous transcatheter device intended to prevent thrombus embolization from the left atrial appendage in patients who have nonvalvular atrial fibrillation.\n\nThis self-expanding LAA Occluder consists of an umbrella and a cover connected by a central waist. Although the first generation of LAmbre LAAO device is associated with high implantation success rate of 99.7% and a relatively low major procedure-related complication rate of 2.9%, to better match the challenging anatomy of the LAA and to further improve procedural safety, the first generation of LAmbre LAAO device has been upgraded.\n\nThe LAmbre™ II Left Atrial Appendage Occluder, designed to prevent thrombus embolization and reduce the risk of bleeding events in patients with non-valvular atrial fibrillation, is being evaluated in a prospective, single-center, single-arm First In Man (FIM) study. The study, conducted at the Prince of Wales Hospital, Chinese University of Hong Kong, aims to assess the preliminary safety and feasibility of the device and its Occluder Delivery System in 10 subjects who are at increased risk for stroke and systemic embolism, either due to their anticoagulation therapy eligibility or contraindications.\n\nThe enrollment period is expected to take approximately 6 months and subjects will have follow-up before discharge and at 30 days, 3M, 6M, 12M months post-operation. The total study duration is expected to be approximately 19 months.",[27],[86,87,88,89,90],"non valvular atrial fibrillation","Left Atrial Appendage","Left Atrial Appendage Occluder","Left Atrial Appendage Occlusion","Stroke prevention","NOT_YET_RECRUITING","2026-03-02",{"date":94,"type":34},"2026-03-06",{"date":96,"type":21},"2026-04-01",{"date":98,"type":21},"2028-05-01",{"name":100,"class":70},"Prince of Wales Hospital, Shatin, Hong Kong",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":111,"conditions":112,"keywords":119,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":71},"100589046","stroke-risk-assessment-and-markers-of-blood-clotting-in-patients-with-newly-diagnosed-non-valvular-atrial-fibrillation-nvaf-who-have-not-received-oral-anticoagulation-therapy-oac-therapy-prior-to-inclusion-100589046","NCT06949319","Stroke Risk Assessment and Markers of Blood Clotting in Patients With Newly Diagnosed Non-valvular Atrial Fibrillation (NVAF), Who Have Not Received Oral Anticoagulation Therapy (OAC-therapy) Prior to Inclusion","Individualized Stroke Risk Scores and Hemostatic Profile in Oral Anticoagulant-naïve (OAC-naïve) Patients With Non-valvular Atrial Fibrillation (NVAF)","BIO-AF","Inclusion Criteria:\n\n* Patients with newly diagnosed non-valvular atrial fibrillation (NVAF), who are oral anticoagulant-naïve (OAC-naïve) prior to inclusion.\n* Age ≥ 18 years.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Ongoing OAC treatment prior to inclusion.\n* Valvular AF (mechanical heart valves or moderate-severe mitral stenosis).\n* Secondary AF due to an acute reversible precipitant (e.g., infection, surgery, thyrotoxicosis, etc.).\n* Pregnant or breastfeeding women.\n* Treatment with oral contraceptives.\n* End-stage renal disease (creatinine clearance \\\u003C15 mL\u002Fmin as calculated by the Cockcroft-Gault equation).\n* Connective tissue diseases.\n* Active cancer (cancer diagnosis not followed by curative procedures six months from the date of diagnosis).\n* Major surgery (\\\u003C three months).\n* Acute coronary syndrome, stroke\u002FTIA, and venous thromboembolism within three months prior to inclusion.\n* Thrombophilia.\n* Significant liver disease.\n* Significant hematological disease.",{"count":110,"type":21},150,"Background:\n\nAtrial fibrillation (AF) is the most common heart rhythm disorder worldwide. Globally, there are 37.5 million people with AF. AF increases the risk of death, heart failure, and stroke, which severely affect patients and also lead to high healthcare costs. Around 25% of all strokes are caused by AF, and patients with stroke due to AF tend to have a higher risk of death and more disability compared to stroke patients without AF.\n\nStroke prevention is, therefore, an important part of AF treatment, in which blood thinning medication has an important role. However, blood thinners increase the risk of bleeding. Therefore, it is important to divide patients with AF into different risk groups, known as risk assessment, to figure out who will benefit the most from blood thinners. To be able to divide patients into different risk groups, various stroke risk assessment tools have been developed, such as the CHA2DS2-VASc score and the ABC-stroke score. The most commonly used tool is the CHA2DS2-VASc score, including only clinical risk factors, such as high blood pressure, diabetes, etc. The ABC-stroke score, which includes blood markers of heart function, has been proven to outperform the CHA2DS2-VASc score in terms of predicting stroke in AF patients. However, the CHA2DS2-VASc score remains the primary stroke risk assessment tool for AF patients in current guidelines.\n\nAfter looking at the different risk factors, patients are divided into three groups: low, intermediate, and high risk. High-risk patients must take blood-thinning medication for life, while low-risk patients do not need it. In the medium-risk group, it remains uncertain whether blood thinners should be given or not.\n\nDespite the broad use of the CHA2DS2-VASc score, the score itself has limitations. The score does not include important factors, such as the duration of AF, the size and function of the upper heart chambers, as well as the stiffness of the heart, and markers of blood clotting, which are proven markers of a state that inceases the risk of blood clots. Furthermore, the CHA2DS2-VASc score does not consider whether heart failure, high blood pressure, and diabetes are well-controlled or not, which could lead to overuse of blood thinners. Therefore, the current risk assessment tools for patients with AF are incomplete, and improvements are needed.\n\nOverall hypothesis:\n\nOverall hypothesis is that the different components of the CHA2DS2-VASc score and ABC-stroke score affect blood clotting markers differently, depending on whether conditions like heart failure, high blood pressure, and diabetes (modifiable risk factors) are well-controlled or not. Investigators also expect to see differences in blood clotting markers across different stroke risk groups (low, intermediate, and high risk, based on the CHA2DS2-VASc score and ABC-stroke score) in AF patients who have not yet started blood thinning medication. Furthermore, investigators believe that the duration of AF, the size\u002Ffunction of the upper heart chambers, as well as the stiffness of the heart, can reflect an increased risk of blood clots in AF patients.\n\nOverall goal of the study:\n\nThe overall goal of the study is to help improve the current tools used to assess the risk of stroke in patients with newly diagnosed AF. This will be done by adding more factors to the current risk assessment tools that reflect an increased risk of stroke, such as the burden of AF, the size\u002Ffunction of the heart's upper chambers, as well as the stiffness of the heart, and using biomarkers that show the blood's ability to clot as a substitute measure for stroke risk.\n\nMethods:\n\nThe study is a cross-sectional, single-center observational study and will take place at Esbjerg Hospital - University Hospital of Southern Denmark, involving collaboration between the Unit for Thrombosis Research, Department of Clinical Diagnostics and the Department of Cardiology.\n\nThe study population will consist of 150 participants with newly diagnosed AF. The participants must not be taking a specific type of blood thinner, called anticoagulant therapy (OAC-therapy), before being included in the study. The participants will be recruited with the help of the general practitioners (GPs). The general practitioners will be thoroughly informed about the study and the importance of waiting to start OAC-therapy until the participants have been seen at the cardiology outpatient clinic. The participants will be scheduled for a blood test, an ultrasound of the heart (echocardiography), and a 7-day heart rhythm monitoring within 4 days after their first meeting with the GP.",[113,114,115,27,116,117,118],"Atrial Fibrillation (AF)","Atrial Fibrillation (Prevention of Stroke)","Atrial Fibrillation New Onset","Stroke (in Patients With Atrial Fibrillation)","Stroke","Thrombosis",[120,121,122,123,124,125,126,127,128,129,130,117,131,132],"Stroke risk assessment in patients with atrial fibrillation","OAC-naïve patients with newly diagnosed atrial fibrillation","Hemostatic biomarkers","CHA2DS2-VASc score","ABC-stroke score","AF-burden","Left Atrial Function Index (LAFI)","Echocardiography","HFA-PEFF score","H2FPEF score","Heart failure with preserved ejection fraction (HFpEF)","Oral anticoagulant therapy","Non-valvular atrial fibrillation","2025-04-21",{"date":135,"type":34},"2025-04-29",{"date":137,"type":34},"2024-08-16",{"date":139,"type":21},"2025-09",{"name":141,"class":70},"Nedim Tojaga",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":5},"100405428","left-atrial-appendage-closure-as-secondary-prevention-of-atrial-fibrillation-related-embolic-events-100405428","NCT04559243","Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events","A Prospective, Multicenter Clinical Study of Percutaneous Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events in Patients With Atrial Fibrillation","Inclusion Criteria:\n\n* Age ≥ 18 years, male or female;\n* Patients who are able to understand the purpose of the study, voluntarily participate in and sign the informed consent form (ICF), and are willing to complete the follow-up as required by the protocol;\n* Indications for left atrial appendage closure;\n* Patients with non-valvular AF complicated with previous AF related embolic event and meeting one of the following conditions;\n\n  1. HAS-BLED bleeding risk score ≥ 3 points;\n  2. Not suitable for long-term oral anticoagulant therapy;\n  3. Poor compliance with oral anticoagulants;\n  4. CHA2DS2-VASc score ≧ 2 points;\n\nExclusion Criteria:\n\n* Valvular AF (after moderate to severe mitral stenosis or mechanical valve replacement)\n* Initial AF, reversible AF with clear cause\n* Presence of adherent thrombus in the left atrium or left ventricular aneurysm thrombus\n* ST elevation myocardial infarction, ≤ 3 months\n* Grade-IV of Cardiac Function (NYHA)\n* Allergy or contraindication to metal nitinol, aspirin, clopidogrel, heparin, and other anticoagulants\n* Pregnant or with plan of pregnancy during the study\n* Participation in another drug or medical device clinical trial or study that has not been completed\n* Experience new stroke or TI within 30 days or major bleeding events within 14 days\n* Contraindication to LAA closure or deemed unsuitable for study participation by the investigator\n* Had a definite thromboembolic event",{"count":150,"type":21},579,"This clinical study is a prospective, multi-center, non-interventional study designed to investigate the safety and effectiveness of percutaneous LAA appendage closure by using LAmbre™ Left Atrial Appendage Occluder System. 579 patients with valvular AF complicated with previous AF-related embolic events (including ischemic stroke, TIA and systemic embolism) were enrolled at about 20 study sites nationwide. The baseline data, operation process and relevant follow-up information of subjects were recorded at 7 months after operation or before discharge and at 1, 3, 6, 12 and 24 months after operation.",[56,153],"Embolic Stroke",[155,156,157],"AF-related embolic events","non-valvular atrial fibrillation","Left Atrial Appendage Closure","2022-12-15",{"date":160,"type":34},"2022-12-19",{"date":162,"type":34},"2020-11-12",{"date":164,"type":21},"2027-11",{"name":166,"class":41},"Lifetech Scientific (Shenzhen) Co., Ltd."]