[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520772":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":58,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Deutsches Herzzentrum Muenchen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LAmbre occlusion device","EXPERIMENTAL","Left atrial occlusion will be performed with the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China)",[13],"Device: Left Atrial Appendage Occlusion",{"label":15,"type":16,"description":17,"interventionNames":18},"AMPLATZER Amulet occlusion device","ACTIVE_COMPARATOR","Left atrial occlusion will be performed with AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA)",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Left Atrial Appendage Occlusion","Left Atrial Appendage Occlusion will be performed according to current international standards by experienced operators under TOE and angiographic guidance. Either a LAmbre occlusion device (group A) or an AMPLATZER Amulet occlusion device (group B) will be implanted depending on treatment allocation.",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Michael Joner, MD","Klinik für Herz- und Kreilauferkankungen, Deutsches Herzzentrum München","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","+4989-1218-2869","joner@dhm.mhn.de",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Tobias Rheude, MD","+4989-1218-2985","rheude@dhm.mhn.de",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München","RECRUITING","Munich","Bavaria","80636","Germany","DE",{"type":50,"coordinates":51},"Point",[52,53],11.57549,48.13743,{"lat":53,"lon":52},[56],{"name":37,"role":33,"phone":57,"phoneExt":25,"email":39},"+49 89 1218 2985",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[61],{"name":62,"class":63},"Lifetech Scientific (Shenzhen) Co., Ltd.","INDUSTRY","100520772","lambre-versus-amplatzer-amulet-left-atrial-appendage-occluder-for-stroke-prophylaxis-100520772",false,"NCT06060912","LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs","LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs: The Randomized AMPIRI Trial","AMPIRI","Inclusion Criteria:\n\n* Age ≥ 18 years and able to give consent\n* Documented paroxysmal, persistent or permanent non-valvular atrial fibrillation\u002F atrial flutter (AF) at high risk of stroke or systemic embolism defined by CHA2DS2-VASc score ≥ 2 (male) or ≥ 3 (female)\n* Patient not eligible for long-term oral anticoagulation therapy\n* Deemed suitable for percutaneous LAAO\n* Able to comply with the required medication regimen after LAAO device implantation\n* Written informed consent\n* LAA anatomy can accommodate either a LAmbre or AMPLATZER Amulet LAAO device, as per manufacturer's instruction for use (IFU) (the anatomy and sizing must be appropriate for both devices in order to be enrolled in the trial)\n* For women of childbearing potential, negative pregnancy test and agree to use reliable method of birth control during the study\n\nExclusion Criteria:\n\n1. Indication for long-term oral anticoagulation therapy for a condition other than AF (i. e. pulmonary embolism, mechanical heart valve)\n2. LAA is obliterated or surgically ligated\n3. Known allergy or hypersensitivity to any component of the LAAO devices or components of the required medication regimen\n4. Prior atrial septal defect (ASD) repair or implantation of ASD closure device\n5. Active endocarditis or other infection producing bacteremia\n6. Significant symptomatic carotid artery disease\n7. Participation in a concurrent clinical trial, which may confound the results of this trial\n8. Patient cannot adhere to or complete the trial protocol for any reason\n\n   Or any of the following echocardiographic exclusion criteria:\n9. Intracardiac thrombus\n10. Intracardiac tumor\n11. Existing, clinically relevant circumferential pericardial effusion\n12. Significant mitral valve stenosis","ALL","18 Years","100 Years",{"count":76,"type":77},226,"ESTIMATED","INTERVENTIONAL",[80],"NA","The objective of this trial is to compare two different commercially available left atrial appendage occlusion (LAAO) devices in patients with non-valvular Atrial fibrillation\u002F atrial flutter (AF) at increased risk for stroke with regard to safety and efficacy.\n\nThe investigators hypothesize that LAAO using the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China) is non-inferior to LAAO using the AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA) with regards to the primary endpoint, which is peri-device leak (PDL) size 3 months after LAAO, as assessed with transesophageal echocardiography (TOE) in patients with non-valvular AF.",[22],[22,84,85],"Non-pharmacological anticoagulation therapy","Stroke prophylaxis","2024-01-07",{"date":88,"type":89},"2024-01-09","ACTUAL",{"date":91,"type":89},"2023-12-05",{"date":93,"type":77},"2027-10-15",{"name":5,"class":6},1]