[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stroke-prevention-in-patients-with-atrial-fibrillation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stroke-prevention-in-patients-with-atrial-fibrillation":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,84],{"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":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100619784","option-emea-clinical-trial-100619784",false,"NCT07349121","OPTION-EMEA Clinical Trial","Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation - Europe, Middle East and Africa [OPTION-EMEA]","OPTION-EMEA","Inclusion Criteria:\n\n1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN FLX™ Pro or WATCHMAN FLX™ for LAAC, per physician medical judgement and as per hospitals' standard of care.\n2. Subjects who are willing and able to provide informed consent.\n3. Subjects who are willing and able to participate in all testing associated with this clinical study at an approved investigational center.\n4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.\n\nExclusion Criteria:\n\n1. Subjects who underwent prior AF ablation procedure.\n2. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible \u002F non-cardiac causes.\n3. Already surgically closed or otherwise excluded LAA.\n4. The LAA anatomy does not accommodate a Closure Device.\n5. Known or suspected atrial myxoma.\n6. Presence of intracardiac thrombus\\*.\n7. Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an atrial septal defect (ASD) \u002F patent foramen ovale (PFO) device.\n8. Subjects with a presence of a mechanical valve prosthesis in any position.\n9. Subjects with a myocardial infarction within 90 days prior to enrollment.\n10. Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within 90 days prior to enrollment.\n11. Any planned electrical cardioversion within 30 days following LAAC device implant.\n12. Subjects with a known inability to obtain vascular access.\n13. Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present.\n14. Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina).\n15. Subjects with any contraindications to short term use of anticoagulation therapy for conditions different from atrial fibrillation.\n16. Subjects who are pregnant or planning to be pregnant.\n17. Subjects with a life expectancy of ≤ 1 year per investigator's opinion.\n18. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be reviewed by the sponsor to determine eligibility.","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"NA","The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one interventional case.\n\nThe study will include patients that are clinically indicated for atrial fibrillation (AF) ablation using the FARAPULSE PFA System and for left atrial appendage closure (LAAC) treatment using a WATCHMAN FLX Pro or WATCHMAN FLX device as part of the patient's standard of care determined by their doctor's medical judgement.",[27,28,29,30,31,32],"Atrial Fibrillation (AF)","Stroke Prevention in Patients With Atrial Fibrillation","Left Atrial Appendage Closure","Pulsed Field Ablation","Atrial Fibrillation Ablation Procedure","Concomitant Procedures",[34,35,36,37,38],"WATCHMAN","FARAPULSE","Concomitant","PFA","LAAC","RECRUITING","2026-06-26",{"date":42,"type":43},"2026-06-30","ACTUAL",{"date":45,"type":43},"2026-06-18",{"date":47,"type":21},"2029-12",{"name":49,"class":50},"Boston Scientific Corporation","INDUSTRY",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100639683","clot-less---closure-tailored-less-antithrombotic-strategy-after-laac-for-stroke-prevention-100639683","NCT07575867","CLOT-LESS - CLOsure Tailored: LEss Antithrombotic Strategy After LAAC for Stroke Prevention","CLOT-LESS","Inclusion Criteria:\n\n* Age ≥18 years;\n* Documented nonvalvular AF (≥30 seconds on ECG within previous 12 months);\n* CHA2DS2-VASc score ≥3 for women and ≥2 for men;\n* Signed informed consent to participate in the study;\n\nExclusion Criteria:\n\n* Active indication for anticoagulation OTHER than atrial fibrillation at the time of enrollment and\u002For the predicted\u002Funpredicted occurrence of such indications during the entire study period (e.g., mechanical valve, acute VTE, recent PE requiring \\>3 months anticoagulation);\n* Inability to tolerate at least 3 months of apixaban therapy (for LAAC arm);\n* Indications for antiplatelet therapy or therapy with P2Y12 inhibitors at the time of inclusion and\u002For the predicted\u002Funpredicted occurrence of such indications during the entire study period;\n* The presence of mechanical prosthetic heart valves, mitral stenosis of severe or moderate degree;\n* Active DVT requiring anticoagulation;\n* Congenital or acquired haemostasis disorders, rheumatic heart disease or recurrent deep vein thrombosis;\n* Left ventricular ejection fraction (LVEF) \\\u003C 30%;\n* Glomerular filtration rate (GFR) \\\u003C 30 ml\u002Fmin (stage IV or V chronic kidney disease) or dialysis patient;\n* Severe liver failure, including cirrhosis and Child-Pugh Class C\u002FD;\n* NYHA class IV congestive heart failure;\n* The patient had a myocardial infarction - MI with or without ST segment elevation (STEMI, NSTEMI) with or without intervention, within 30 days before LAAC;\n* The patient had a stroke (of any cause, ischemic or hemorrhagic) within 30 days before LAAC;\n* Intracardiac thrombus before LAAC;\n* Major bleeding according to BARC criteria (type 3 and higher) within 30 days before LAAC or before randomization;\n* Amyloid cardiomyopathy;\n* Platelet count \\\u003C 100,000 x 109\u002Fl;\n* The patient participates in another study, with the exception of observational studies without therapeutic interventions;\n* Pregnant or breast-feeding patients, patients planning pregnancy during the study period;\n* The LAAC procedure was unsuccessful or interrupted for technical reasons;\n* PDL (peridevice leak) ≥ 3 mm;\n* Contraindications for one of the treatment regimens prescribed by the study protocol (including allergic reactions);\n* Planned cardiac or non-cardiac surgical procedure within 30 days before or 90 days after LAAC. Minor procedures not requiring discontinuation of antithrombotic therapy are permitted (e.g., cardioversion, catheter ablation, cataract surgery);\n* The patient has a heart tumor, active infection, signs of physiological tamponade;\n* The documented life expectancy of the patient is less than 12 months;",{"count":59,"type":21},464,"OBSERVATIONAL","This is a prospective, non-randomized, observational cohort study conducted at the FSBI \"NMRC TPM\" of the Ministry of Healthcare of the Russian Federation. Left atrial appendage closure (LAAC) has been shown to be non-inferior to oral anticoagulation for preventing cardioembolic events in patients with atrial fibrillation. However, the optimal post-procedural antithrombotic regimen following LAAC remains unclear, with no consensus on evidence-based therapy. Given current trends in cardiology favoring reduced-intensity antithrombotic strategies, this study aims to contribute to the evidence base by evaluating whether LAAC followed by reduced-dose apixaban (2.5 mg BID) for 3 months with subsequent complete withdrawal of antithrombotic therapy is superior to long-term standard-dose DOAC therapy in patients with non-valvular atrial fibrillation.",[63,28,29,64,65,66,67],"Atrial Fibrillation","Hemorrhage","Anticoagulants \u002F Administration & Dosage","Reduced-dose Apixaban","Thromboembolism",[69,70,71,72],"atrial fibrillation","left atrial appendage closure","anticoagulants","reduced dose apixaban","2026-05-04",{"date":75,"type":43},"2026-05-08",{"date":77,"type":21},"2026-04",{"date":79,"type":21},"2032-04",{"name":81,"class":82},"National Medical Research Center for Therapy and Preventive Medicine","OTHER_GOV",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":93,"studyType":60,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":83},"100612748","left-atrial-appendage-occlusion-in-dialysis-patients-with-atrial-fibrillation-a-multicentre-pilot-study-100612748","NCT07257614","Left Atrial Appendage Occlusion in Dialysis Patients With Atrial Fibrillation: A Multicentre Pilot Study","LAAO-DAF","Inclusion Criteria:\n\n* Age \\>=18\n* End stage renal failure on peritoneal dialysis or haemodialysis\n* documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;\n* CHADS2-VASc \\>=2\n* The patient is willing and able to comply with the required medication post-procedure and follow-up evaluations;\n* Able to consent\n\nExclusion Criteria:\n\n* Patients who require long-term anticoagulation for a condition other than AF, e.g. pulmonary embolism, deep vein thrombosis, anti-phospholipid syndrome\n* Mechanical valve replacement\n* Active infection with bacteraemia;\n* Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy\n* Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, any device material or component (nickel titanium, PET, polypropylene), and\u002For contrast;\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, etc.);\n* Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;\n* New York Heart Association Class IV;\n* Life expectancy is less than 1 year;\n* Current participation in another investigational drug or device study.\n* Echocardiogram exclusion:\n\n  i. Moderate mitral stenosis or above ii. LVEF \\\u003C30% iii. Intracardiac thrombus iv. Presence of a cardiac tumour. v. Existing circumferential pericardial effusion \\>5 mm; vi. 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)",{"count":92,"type":21},40,"1 Year","Objectives: This pilot study aims to evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) in dialysis patients and atrial fibrillation (AF) to establish a novel stroke prevention strategy and determine an optimal post-occlusion antithrombotic regime. Page 3 of 50 Hypothesis: The study tests the hypotheses that LAAO is safe for dialysis patients, that a single antiplatelet regimen postprocedure is safe, and that LAAO effectively reduces the composite endpoint of stroke\u002Ftransient ischemic attack and major bleeding compared to standard care. Instruments: The study employs a multicenter, single-arm prospective registry design. Eligible participants, aged ≥18 with documented AF and ESRF on peritoneal dialysis (PD) or hemodialysis (HD), will undergo LAAO using the Watchman Flx PRO device. Propensity score matched historical cohort from dialysis registry will be identified for comparison.\n\nMain Outcome Measures: The primary endpoint is the composite of stroke\u002Ftransient ischemic attack\u002Fsystemic embolism and non-procedural-related major bleeding at one year. Secondary endpoints include individual rates of these events, procedural safety and device occlusion effectiveness. Data Analysis and Expected Results: Statistical analysis will involve descriptive statistics, chi-squared tests, and propensity score matching. A p-value of \\\u003C0.05 will be deemed significant. The pilot study anticipates a low peri-procedural complication rate (≤5%) and confirms LAAO's efficacy in stroke and major bleeding reduction in Chinese PD and HD patients compared to standard care. This data will inform the design of a larger randomized controlled trial aimed at validating LAAO as a safe alternative for AF management in dialysis populations.",[96,97,63,98,28,99],"Dialysis","Chronic Kidney Disease (Stages 3b-5)","End Stage Kidney Failure","Left Atrial Appendage Occlusion","NOT_YET_RECRUITING","2025-12-02",{"date":103,"type":43},"2025-12-04",{"date":105,"type":21},"2026-01-05",{"date":107,"type":21},"2028-07-05",{"name":109,"class":110},"Prince of Wales Hospital, Shatin, Hong Kong","OTHER"]