[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628514":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":62,"collaborators":64,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Heart Center Leipzig - University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ViV-TAVR","EXPERIMENTAL","The intervention under investigation is transcatheter - preferably transfemoral - ViV-TAVR applied for degenerated surgical aortic bioprostheses with an indication for re-intervention in patients at low-to-intermediate surgical risk. An aortic transcatheter bioprosthesis is implanted into the degenerated surgical aortic bioprosthesis.",[13],"Procedure: Transfemoral transcatheter valve-in-valve implantation",{"label":15,"type":16,"description":17,"interventionNames":18},"redoAVR","ACTIVE_COMPARATOR","Surgical redoAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.",[19],"Procedure: Surgical redo aortic valve replacement",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Transfemoral transcatheter valve-in-valve implantation","The intervention under investigation is transcatheter\n\n\\- preferably transfemoral - ViV-TAVR applied for degenerated surgical aortic bioprostheses with an indication for re-intervention in patients at low-to intermediate surgical risk. An aortic transcatheter bioprosthesis is implanted into the degenerated surgical aortic bioprosthesis.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Surgical redo aortic valve replacement","Surgical rAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.",[15],[32],{"name":33,"affiliation":34,"role":35},"Michael Borger","University Leipzig","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","03418650","Michael.Borger@helios-gesundheit.de",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":43},"Matthias Raschpichler","matthias.raschpichler@helios-gesundheit.de",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Herzzentrum Leipzig GmbH","RECRUITING","Leipzig","Saxony","04289","Germany","DE",{"type":54,"coordinates":55},"Point",[56,57],12.37129,51.33962,{"lat":57,"lon":56},[60,61],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":42,"role":38,"phone":26,"phoneExt":26,"email":43},{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[65,67],{"name":66,"class":6},"University of Leipzig",{"name":68,"class":6},"Helios Health Institute GmbH","100628514","repeat-intervention-for-failed-surgical-bioprosthetic-aortic-valves-repeat-100628514",false,"NCT07462624","REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)","REpeat Intervention for Failed Surgical BioProsthEtic AorTic Valves (REPEAT): A Multicenter Randomized Trial Comparing Redo Surgical Aortic Valve Replacement to Valve-in-Valve Transcatheter Aortic Valve Replacement","REPEAT","Inclusion Criteria:\n\n* Indication for repeat intervention for failed surgical aortic bioprosthesis due to structural valve deterioration (SVD; prosthesis stenosis and\u002For transprosthetic insufficiency);\n* Low to intermediate surgical risk (i.e., Society of Thoracic Surgeons (STS) predicted risk of mortality of \\\u003C 8%);\n* Age \\> 18 and \\\u003C 75 years;\n* Both rAVR and ViV-TAVR are judged to be reasonable options based on evaluation by the local Heart Team\n\nExclusion Criteria:\n\n* Multiple valvular disease requiring surgical intervention;\n* High-risk coronary anatomy resulting in increased risk of coronary obstruction following ViV-TAVR prosthesis deployment;\n* Complex coronary artery disease requiring revascularization (unprotected left main coronary artery, Syntax score \\> 32) and Heart Team assessment that optimal revascularization cannot be performed;\n* Failing valve with evidence of bacterial endocarditis or evidence of non-structural valve deterioration (e.g., paravalvular leak, thrombosis);\n* Increased post-procedural gradients (mean \\> 20 mmHg) or severe patient-prosthesis mismatch (PPM, indexed effective orifice area \\\u003C 0.65 cm2\u002Fm2) at discharge from index aortic valve replacement (AVR) procedure;\n* Patients who choose to receive a mechanical AVR.","ALL","18 Years","75 Years",{"count":81,"type":82},890,"ESTIMATED","INTERVENTIONAL",[85],"NA","The overall hypothesis is that redo aortic valve replacement (rAVR) is superior to valve-invalve transcatheter aortic valve replacement (ViV-TAVR) for the composite endpoint of freedom from all-cause mortality, all-cause stroke, myocardial infarction, and rehospitalization for heart failure or aortic valve re-intervention at 5 years.",[88],"Degenerative Aortic Valve Disease","2026-03-05",{"date":91,"type":92},"2026-03-10","ACTUAL",{"date":94,"type":92},"2025-11-10",{"date":96,"type":82},"2033-09-30",{"name":5,"class":6},1]