[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"embolic-stroke\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:embolic-stroke":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100405428","left-atrial-appendage-closure-as-secondary-prevention-of-atrial-fibrillation-related-embolic-events-100405428",false,"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","ALL","18 Years",{"count":19,"type":20},579,"ESTIMATED","OBSERVATIONAL","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.",[24,25],"Non-valvular Atrial Fibrillation","Embolic Stroke",[27,28,29],"AF-related embolic events","non-valvular atrial fibrillation","Left Atrial Appendage Closure","RECRUITING","2022-12-15",{"date":33,"type":34},"2022-12-19","ACTUAL",{"date":36,"type":34},"2020-11-12",{"date":38,"type":20},"2027-11",{"name":40,"class":41},"Lifetech Scientific (Shenzhen) Co., Ltd.","INDUSTRY",5]