[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519907":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":135,"collaborators":24,"id":137,"slug":24,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":24,"eligibilityCriteria":142,"healthyVolunteers":138,"sex":143,"minAge":144,"maxAge":24,"enrollmentInfo":145,"targetDuration":24,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":155,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Fundación EPIC","OTHER",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"NVT ALLEGRA System TF","ACTIVE_COMPARATOR",[12],"Device: NVT ALLEGRA TAVI System TF",{"label":14,"type":15,"description":14,"interventionNames":16},"EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM","EXPERIMENTAL",[17],"Device: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM",[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","NVT ALLEGRA TAVI System TF","Transcatheter aortic valve implantation of a NVT ALLEGRA TAVI System TF in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically",[9],null,{"type":20,"name":14,"description":26,"armGroupLabels":27,"otherNames":24},"Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically",[14],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"RAÚL MORENO GÓMEZ, MD, PhD","CONTACT","0034917277000","raulmorenog@hotmail.com",{"name":35,"role":31,"phone":36,"phoneExt":24,"email":37},"FUNDACION EPIC","0034987876135","iepic@fundacionepic.org",[39,50,58,68,77,83,92,101,110,119,127],{"facility":40,"status":41,"city":42,"state":24,"zip":24,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":24},"Azienda Ospedaliero- Universitaria di Alessandria","RECRUITING","Alessandria","Italy",{"type":45,"coordinates":46},"Point",[47,48],8.61007,44.90924,{"lat":48,"lon":47},{"facility":51,"status":41,"city":52,"state":24,"zip":24,"country":43,"cosmosGeoPoint":53,"geoPoint":57,"contacts":24},"Azienda Ospedaliera di Perugia","Perugia",{"type":45,"coordinates":54},[55,56],12.38878,43.1122,{"lat":56,"lon":55},{"facility":59,"status":41,"city":60,"state":24,"zip":61,"country":62,"cosmosGeoPoint":63,"geoPoint":67,"contacts":24},"Hospital Universitari de Bellvitge","L'Hospitalet de Llobregat","08907","Spain",{"type":45,"coordinates":64},[65,66],2.10028,41.35967,{"lat":66,"lon":65},{"facility":69,"status":41,"city":70,"state":24,"zip":71,"country":62,"cosmosGeoPoint":72,"geoPoint":76,"contacts":24},"Hospital Clinico San Carlos","Madrid","28040",{"type":45,"coordinates":73},[74,75],-3.70256,40.4165,{"lat":75,"lon":74},{"facility":78,"status":41,"city":70,"state":24,"zip":79,"country":62,"cosmosGeoPoint":80,"geoPoint":82,"contacts":24},"Hospital Universitario de La Paz","28046",{"type":45,"coordinates":81},[74,75],{"lat":75,"lon":74},{"facility":84,"status":41,"city":85,"state":24,"zip":86,"country":62,"cosmosGeoPoint":87,"geoPoint":91,"contacts":24},"Hospital Universitario Puerta De Hierro","Majadahonda","28222",{"type":45,"coordinates":88},[89,90],-3.87182,40.47353,{"lat":90,"lon":89},{"facility":93,"status":41,"city":94,"state":24,"zip":95,"country":62,"cosmosGeoPoint":96,"geoPoint":100,"contacts":24},"Hospital Clínico Universitario de Salamanca","Salamanca","37007",{"type":45,"coordinates":97},[98,99],-5.66388,40.96882,{"lat":99,"lon":98},{"facility":102,"status":41,"city":103,"state":24,"zip":104,"country":62,"cosmosGeoPoint":105,"geoPoint":109,"contacts":24},"Hospital Universitari I Politècnic de La Fe","Valencia","46026",{"type":45,"coordinates":106},[107,108],-0.37966,39.47391,{"lat":108,"lon":107},{"facility":111,"status":41,"city":112,"state":24,"zip":24,"country":113,"cosmosGeoPoint":114,"geoPoint":118,"contacts":24},"Manchester University NHS Foundation Trust","Manchester","United Kingdom",{"type":45,"coordinates":115},[116,117],-2.23743,53.48095,{"lat":117,"lon":116},{"facility":120,"status":41,"city":121,"state":24,"zip":24,"country":113,"cosmosGeoPoint":122,"geoPoint":126,"contacts":24},"Freeman Hospital","Newcastle",{"type":45,"coordinates":123},[124,125],-5.88979,54.21804,{"lat":125,"lon":124},{"facility":128,"status":41,"city":129,"state":24,"zip":24,"country":113,"cosmosGeoPoint":130,"geoPoint":134,"contacts":24},"Morriston Hospital, Swansea","Swansea",{"type":45,"coordinates":131},[132,133],-3.94323,51.62079,{"lat":133,"lon":132},{"type":136,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100519907",false,"NCT06049654","Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication","Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication","Inclusion Criteria:\n\nPatients meeting ALL the following criteria will be included:\n\n* Patients aged ≥ 18 years.\n* Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area \\\u003C 1.0 cm2) and\u002For severe valve regurgitation.\n* The patient has cardiac symptoms and\u002For deterioration of left ventricular ejection fraction attributable to the aortic valve disease.\n* Heart team decision of VIV procedure.\n* Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year.\n\nExclusion Criteria:\n\nPatients meeting, at least, 1 of the following criteria will be excluded:\n\n* Patients who openly express their refusal to participate in the study.\n* Female patients in gestational age.\n* Presence or suspicious of biological aortic valve thrombosis.\n* Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.\n* Ongoing sepsis and\u002For suspicious or diagnosis of endocarditis.\n* Patients whose life expectancy is \\\u003C 1 year due to non-cardiac comorbid conditions.\n* Medical, social, or psychological conditions that preclude the subject from appropriate consent or adherence to the protocol required follow-up exams.\n* True inner diameter of the prosthetic valve \\> 27 mm.\n* Transfemoral access inadequate to accommodate an 18F sheath.\n* Patients included in other clinical trials (excluding registries).","ALL","18 Years",{"count":146,"type":147},104,"ESTIMATED","INTERVENTIONAL",[150],"NA","The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.",[153,154],"Aortic Valve Stenosis","Structural Valve Deterioration",[156,157,158,159,160],"Valve-In-Valve","Aortic stenosis","Aortic regurgitation","Trans-catheter aortic valve","Degenerated aortic valve","2026-06-12",{"date":163,"type":164},"2026-06-15","ACTUAL",{"date":166,"type":164},"2024-02-01",{"date":168,"type":147},"2027-11-01",{"name":5,"class":6},11]