[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100405428":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":22,"locations":27,"responsibleParty":106,"collaborators":7,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":7,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":7,"enrollmentInfo":117,"targetDuration":7,"studyType":120,"phases":7,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":30,"whyStopped":7,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Lifetech Scientific (Shenzhen) Co., Ltd.","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DIAGNOSTIC_TEST","Transthoracic Echocardiography","After the surgey, the tests data will be collected during 8 visits when the subjects go back to the hospital.",[14],"Transesophageal Echocardiography",[16,20],{"name":17,"affiliation":18,"role":19},"Chenyang Jiang, Doctor","Sir Run Run Shaw Hospital","PRINCIPAL_INVESTIGATOR",{"name":21,"affiliation":18,"role":19},"Jinhua Zhang, Doctor",[23],{"name":17,"role":24,"phone":25,"phoneExt":7,"email":26},"CONTACT","8613857190051","panshangming@lifetechmed.com",[28,48,63,79,95],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Qilu Hospital of Shandong University","RECRUITING","Jinan","Shandong","250000","China","CN",{"type":37,"coordinates":38},"Point",[39,40],116.99722,36.66833,{"lat":40,"lon":39},[43,47],{"name":44,"role":24,"phone":45,"phoneExt":7,"email":46},"Zhong Jingquan, Doctor","18560086597","18560086597@163.com",{"name":44,"role":19,"phone":7,"phoneExt":7,"email":7},{"facility":49,"status":30,"city":50,"state":51,"zip":52,"country":34,"countryCode":35,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Shanghai Songjiang District Central Hospital","Shanghai","Shanghai Municipality","200000",{"type":37,"coordinates":54},[55,56],121.45806,31.22222,{"lat":56,"lon":55},[59,62],{"name":60,"role":24,"phone":61,"phoneExt":7,"email":7},"Zhao Wenbiao, Doctor","18918288026",{"name":60,"role":19,"phone":7,"phoneExt":7,"email":7},{"facility":64,"status":30,"city":65,"state":66,"zip":67,"country":34,"countryCode":35,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Sichuan Mianyang 404 Hospital","Mianyang","Sichuan","621000",{"type":37,"coordinates":69},[70,71],104.68168,31.46784,{"lat":71,"lon":70},[74,78],{"name":75,"role":24,"phone":76,"phoneExt":7,"email":77},"Zhang Dayong, Doctor","13890135264","504082447@qq.com",{"name":75,"role":19,"phone":7,"phoneExt":7,"email":7},{"facility":80,"status":30,"city":81,"state":82,"zip":83,"country":34,"countryCode":35,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"The first Affiliated Hospital of WMU","Wenzhou","Zhejiang","325600",{"type":37,"coordinates":85},[86,87],120.66682,27.99942,{"lat":87,"lon":86},[90,94],{"name":91,"role":24,"phone":92,"phoneExt":7,"email":93},"Huang Weijian, Doctor","13806691086","weijianhuang69@126.com",{"name":91,"role":19,"phone":7,"phoneExt":7,"email":7},{"facility":96,"status":30,"city":81,"state":82,"zip":83,"country":34,"countryCode":35,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"The Second Affiliated Hospital and Yuying Children's Hospital of WMU",{"type":37,"coordinates":98},[86,87],{"lat":87,"lon":86},[101,105],{"name":102,"role":24,"phone":103,"phoneExt":7,"email":104},"Li Yuechun, Doctor","13616776960","liyuechun1980@sina.com",{"name":102,"role":19,"phone":7,"phoneExt":7,"email":7},{"type":107,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","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":118,"type":119},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.",[123,124],"Non-valvular Atrial Fibrillation","Embolic Stroke",[126,127,128],"AF-related embolic events","non-valvular atrial fibrillation","Left Atrial Appendage Closure","2022-12-15",{"date":131,"type":132},"2022-12-19","ACTUAL",{"date":134,"type":132},"2020-11-12",{"date":136,"type":119},"2027-11",{"name":5,"class":6},5]