[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519907":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":138,"collaborators":24,"id":140,"slug":24,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":24,"eligibilityCriteria":145,"healthyVolunteers":141,"sex":146,"minAge":147,"maxAge":24,"enrollmentInfo":148,"targetDuration":24,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":158,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"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",[39,51,59,70,79,85,94,103,112,122,130],{"facility":40,"status":41,"city":42,"state":24,"zip":24,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":24},"Azienda Ospedaliero- Universitaria di Alessandria","RECRUITING","Alessandria","Italy","IT",{"type":46,"coordinates":47},"Point",[48,49],8.61007,44.90924,{"lat":49,"lon":48},{"facility":52,"status":41,"city":53,"state":24,"zip":24,"country":43,"countryCode":44,"cosmosGeoPoint":54,"geoPoint":58,"contacts":24},"Azienda Ospedaliera di Perugia","Perugia",{"type":46,"coordinates":55},[56,57],12.38878,43.1122,{"lat":57,"lon":56},{"facility":60,"status":41,"city":61,"state":24,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":24},"Hospital Universitari de Bellvitge","L'Hospitalet de Llobregat","08907","Spain","ES",{"type":46,"coordinates":66},[67,68],2.10028,41.35967,{"lat":68,"lon":67},{"facility":71,"status":41,"city":72,"state":24,"zip":73,"country":63,"countryCode":64,"cosmosGeoPoint":74,"geoPoint":78,"contacts":24},"Hospital Clinico San Carlos","Madrid","28040",{"type":46,"coordinates":75},[76,77],-3.70256,40.4165,{"lat":77,"lon":76},{"facility":80,"status":41,"city":72,"state":24,"zip":81,"country":63,"countryCode":64,"cosmosGeoPoint":82,"geoPoint":84,"contacts":24},"Hospital Universitario de La Paz","28046",{"type":46,"coordinates":83},[76,77],{"lat":77,"lon":76},{"facility":86,"status":41,"city":87,"state":24,"zip":88,"country":63,"countryCode":64,"cosmosGeoPoint":89,"geoPoint":93,"contacts":24},"Hospital Universitario Puerta De Hierro","Majadahonda","28222",{"type":46,"coordinates":90},[91,92],-3.87182,40.47353,{"lat":92,"lon":91},{"facility":95,"status":41,"city":96,"state":24,"zip":97,"country":63,"countryCode":64,"cosmosGeoPoint":98,"geoPoint":102,"contacts":24},"Hospital Clínico Universitario de Salamanca","Salamanca","37007",{"type":46,"coordinates":99},[100,101],-5.66388,40.96882,{"lat":101,"lon":100},{"facility":104,"status":41,"city":105,"state":24,"zip":106,"country":63,"countryCode":64,"cosmosGeoPoint":107,"geoPoint":111,"contacts":24},"Hospital Universitari I Politècnic de La Fe","Valencia","46026",{"type":46,"coordinates":108},[109,110],-0.37966,39.47391,{"lat":110,"lon":109},{"facility":113,"status":41,"city":114,"state":24,"zip":24,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":121,"contacts":24},"Manchester University NHS Foundation Trust","Manchester","United Kingdom","UK",{"type":46,"coordinates":118},[119,120],-2.23743,53.48095,{"lat":120,"lon":119},{"facility":123,"status":41,"city":124,"state":24,"zip":24,"country":115,"countryCode":116,"cosmosGeoPoint":125,"geoPoint":129,"contacts":24},"Freeman Hospital","Newcastle",{"type":46,"coordinates":126},[127,128],-5.88979,54.21804,{"lat":128,"lon":127},{"facility":131,"status":41,"city":132,"state":24,"zip":24,"country":115,"countryCode":116,"cosmosGeoPoint":133,"geoPoint":137,"contacts":24},"Morriston Hospital, Swansea","Swansea",{"type":46,"coordinates":134},[135,136],-3.94323,51.62079,{"lat":136,"lon":135},{"type":139,"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":149,"type":150},104,"ESTIMATED","INTERVENTIONAL",[153],"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.",[156,157],"Aortic Valve Stenosis","Structural Valve Deterioration",[159,160,161,162,163],"Valve-In-Valve","Aortic stenosis","Aortic regurgitation","Trans-catheter aortic valve","Degenerated aortic valve","2026-06-12",{"date":166,"type":167},"2026-06-15","ACTUAL",{"date":169,"type":167},"2024-02-01",{"date":171,"type":150},"2027-11-01",{"name":5,"class":6},11]