[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623427":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":29,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":20,"enrollmentInfo":47,"targetDuration":20,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":61,"whyStopped":20,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":20},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL","AnchorMan® Left Atrial Appendage Occluder System Treatment",[13],"Procedure: Intra-operative application of LAAC",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Intra-operative application of LAAC","Undergoing left atrial appendage occlusion device for followup observation of the time course of device surface with the.endotheliation.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"wenzhi pan","CONTACT","0755-1234567","peden@sina.com",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[30,32,34,36],{"name":31,"class":6},"Ruijin Hospital",{"name":33,"class":6},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"name":35,"class":6},"Zhoupu Hospital, Pudong New Area, Shanghai, China",{"name":37,"class":6},"Changhai Hospital","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",false,"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.","ALL","18 Days",{"count":48,"type":49},306,"ESTIMATED","INTERVENTIONAL",[52],"NA","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.",[55,56],"Non-valvular Atrial Fibrillation (NVAF)","High Risk of Stroke",[58,59,60],"Non-valvular atrial fibrillation (NVAF)","high risk of stroke.","Left Atrial Appendage Occluder System","NOT_YET_RECRUITING","2026-02-02",{"date":64,"type":65},"2026-02-09","ACTUAL",{"date":67,"type":49},"2026-02-08",{"date":69,"type":49},"2027-12-31",{"name":5,"class":6}]