[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-valvular-atrial-fibrillation-nvaf\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-valvular-atrial-fibrillation-nvaf":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100622590","fim-study-of-the-lambre-ii-laa-occluder-in-non-valvular-af-patients-100622590",false,"NCT07385599","FIM Study of the LAmbre™ II LAA Occluder in Non-Valvular AF Patients","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","Inclusion Criteria:\n\n1. The patient age ≥18 years;\n2. The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;\n3. The patient has a CHA2DS2-VASc score of ≥ 2 in men and CHA2DS2-VASc score of ≥ 3 in women;\n4. The patient is recommended for oral anticoagulation therapy, but there is an appropriate rationale for seeking a non-pharmacologic alternative to oral anticoagulation;\n5. 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;\n6. The patient is willing and able to comply with the required medication post-procedure and follow-up evaluations;\n7. 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\n1. 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;\n2. 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);\n3. Patients who require long-term anticoagulation for a condition other than atrial fibrillation;\n4. Bleeding diathesis or coagulopathy;\n5. Patients with rheumatic mitral valve disease, known severe mitral stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis;\n6. Active infection with bacteremia;\n7. Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, any device material or component (nickel titanium, PET, polypropylene), and\u002For contrast sensitivity;\n8. Prior atrial septal defect (ASD) or patient foramen ovale (PFO) surgical repair or implantation of closure device;\n9. Left atrial appendage is obliterated and surgical ligated;\n10. 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.);\n11. Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;\n12. New York Heart Association Class IV;\n13. Patients with severe renal failure (estimated glomerular filtration rate\\\u003C30 ml\u002Fmin\u002F1.73m2);\n14. 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%;\n15. Life expectancy is less than 1 year;\n16. Current participation in another investigational drug or device study.","ALL","18 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"NA","To evaluate the preliminary safety and feasibility of the LAmbreTM II Left Atrial Appendage Occluder and the Occluder Delivery System in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism.",[26],"Non-valvular Atrial Fibrillation (NVAF)",[28,29,30,31,32,33,34],"Lifetech","FIM study","LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System","LAmbre™ II","LAmbre™ II Left Atrial Appendage Occluder","Left Atrial Appendage Occluder","LAmbre™ II LAAO","RECRUITING","2026-06-08",{"date":38,"type":39},"2026-06-10","ACTUAL",{"date":41,"type":39},"2026-01-19",{"date":43,"type":20},"2028-03-01",{"name":45,"class":46},"Lifetech Scientific (Shenzhen) Co., Ltd.","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":47},"100637597","stepwise-vs-standard-anticoagulation-for-af-patients-undergoing-cied-implantation-step-af-100637597","NCT07616414","Stepwise vs Standard Anticoagulation for AF Patients Undergoing CIED Implantation (STEP-AF)","Stepwise Versus Standard Antithrombotic Strategies in Patients With Atrial Fibrillation at High Thromboembolic Risk Undergoing CIED Procedures (STEP-AF Trial)","STEP-AF","Inclusion Criteria:\n\n1. Aged 18 years or older at the time of screening, and able to provide written informed consent;\n2. Scheduled for any CIED procedure (implantation or generator replacement), including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices;\n3. Receiving NOAC therapy for at least 5 consecutive days prior to enrollment;\n4. Diagnosed with non-valvular atrial fibrillation (and\u002For atrial flutter) with a CHA₂DS₂-VASc score ≥2, or scheduled for cardioversion or defibrillation threshold testing during the CIED procedure.\n\nExclusion Criteria:\n\n1. Presence of active systemic or local infection at the time of screening;\n2. Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin, or any other contraindication to NOAC use;\n3. Active bleeding (e.g., gastrointestinal bleeding);\n4. Severe thrombocytopenia, defined as platelet count \\\u003C 50 × 10⁹\u002FL at screening;\n5. Life expectancy \\\u003C1 year;\n6. Pregnancy.",{"count":57,"type":20},424,[23],"This is a multi-center, prospective, open-label, randomized controlled trial (STEP-AF) designed to evaluate the safety of a stepwise anticoagulation strategy compared with the guideline-recommended standard anticoagulation regimen in patients with non-valvular atrial fibrillation at high thromboembolic risk (CHA₂DS₂-VASc score ≥2) undergoing cardiac implantable electronic device (CIED) implantation. A total of 424 eligible patients will be randomized 1:1 to either the stepwise anticoagulation group (reduced-dose NOAC from 24 hours post-surgery to day 7, followed by standard-dose NOAC) or the standard anticoagulation group (standard-dose NOAC resumed 24 hours post-surgery). The primary endpoint is the incidence of clinically significant pocket hematoma within 30 days after surgery. Secondary endpoints include individual components of the primary endpoint and other composite outcomes of major perioperative bleeding events. The study aims to provide evidence-based data for optimizing perioperative anticoagulation regimens in Chinese patients undergoing CIED implantation.",[26,61,62,63,64],"Thromboembolism","Cardiac Implantable Electronic Device","Perioperative Bleeding","Hematoma Postoperative",[66,62,67,68,69,70,71,72,61,63,73,74,75],"Non-valvular atrial fibrillation","CIED","Perioperative Anticoagulation","Non-Vitamin K Antagonist Oral Anticoagulant","NOAC","Stepwise Anticoagulation","Postoperative hematoma","Randomized Controlled Trial","Edoxaban","Rivaroxaban","NOT_YET_RECRUITING","2026-05-23",{"date":79,"type":39},"2026-06-01",{"date":81,"type":20},"2026-05-26",{"date":83,"type":20},"2026-12-31",{"name":85,"class":86},"Fu Wai Hospital, Beijing, China","OTHER",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100623427","a-prospective-single-arm-study-evaluating-the-endothelialization-effect-and-timeline-of-anchorman-left-atrial-appendage-occluder-in-non-valvular-atrial-fibrillation-patients-at-high-risk-of-stroke-100623427","NCT07396493","A Prospective, Single-arm Study Evaluating the Endothelialization Effect and Timeline of AnchorMan® Left Atrial Appendage Occluder in Non-valvular Atrial Fibrillation Patients at High Risk of Stroke","AnchorMan-NVAF","Inclusion Criteria:\n\n1. Age ≥ 18 years with non-valvular atrial fibrillation (NVAF).\n2. High stroke risk: CHA2DS2-VASc score ≥ 2 (Male) or ≥ 3 (Female) AND meeting any of the following:\n\n   1. Documented history of bleeding (\\> 6 months ago) or bleeding tendency (e.g., gingival, nasal, GI, urinary tract, cerebral hemorrhage).\n   2. Intolerance or unwillingness to undergo long-term anticoagulation therapy.\n   3. Recurrent stroke or embolic events despite standardized anticoagulation.\n   4. Predicted high bleeding risk (HAS-BLED score ≥ 3).\n   5. Status post-Left Atrial Appendage Electrical Isolation (LAAEI).\n3. Subject or legal representative understands the study purpose, is willing to cooperate with surgery and follow-up, and has signed the written Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n1. Rheumatic heart disease, moderate-to-severe mitral stenosis\u002Fregurgitation, severe aortic valve disease, or severe LVOT obstruction (gradient \\> 40 mmHg).\n2. Left ventricular ejection fraction (LVEF) \\\u003C 30%.\n3. Complex LAA anatomy unsuitable for LAAO implantation.\n4. Pericardial effusion \\> 10mm.\n5. Planned ablation or cardioversion post-procedure.\n6. Intracardiac thrombus (including left\u002Fright atrium).\n7. Myocardial infarction within the last 3 months.\n8. History of ASD repair or PFO occluder implantation.\n9. History of heart valve replacement (mechanical valve).\n10. Heart transplant recipient.\n11. New-onset ischemic stroke or TIA within the last 30 days.\n12. Severe heart failure (NYHA Class IV).\n13. Severe renal impairment: eGFR \\\u003C 45 ml\u002Fmin\u002F1.73m² or on dialysis.\n14. Hypersensitivity or contraindication to aspirin, clopidogrel, heparin, contrast media, or nitinol.\n15. Pregnant or lactating women, or those planning pregnancy within one year.\n16. Life expectancy \\\u003C 12 months.\n17. Unable to complete 2 months of anticoagulation or 6 months of DAPT for any reason.\n18. Investigator's judgment of poor compliance or inability to complete the study requirements.","18 Days",{"count":96,"type":20},306,[23],"This study aims to evaluate the endotheliation efficacy of the AnchorMane® Left Atrial Appendage Occluder in non-valvular atrial fibrillation patients at high stroke risk. It investigates the rate of complete endotheliation of the occluder at 6 months post-procedure using routine cardiac CTA, providing additional data for clinical application and further product development.\n\nStudy Size and Duration: This study plans to enrol1 306 patients. All participants will undergo follow up immediately after occluder implantation, prior to discharge or within 7 days post-procedure, at 1 month post-procedure, at 3 months post-procedure,and at 6 months post-procedure. The total study duration is projected to be 3 year.\n\nThe expected duration of participation for each participant is approximately 6 months.",[26,100],"High Risk of Stroke",[102,103,104],"Non-valvular atrial fibrillation (NVAF)","high risk of stroke.","Left Atrial Appendage Occluder System","2026-02-02",{"date":107,"type":39},"2026-02-09",{"date":109,"type":20},"2026-02-08",{"date":111,"type":20},"2027-12-31",{"name":113,"class":86},"Shanghai Zhongshan Hospital"]