[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100427212":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":21,"studyPopulation":21,"armGroups":28,"interventions":42,"overallOfficials":53,"centralContacts":60,"locations":65,"responsibleParty":262,"collaborators":264,"id":267,"slug":268,"hasResults":269,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":269,"sex":275,"minAge":276,"maxAge":21,"enrollmentInfo":277,"targetDuration":21,"studyType":280,"phases":281,"briefSummary":283,"conditions":284,"keywords":21,"overallStatus":68,"whyStopped":21,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":295},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Device success","Defined by:\n\n* Absence of procedural mortality; AND\n* Technical success at exit from the procedure room defined as freedom from mortality, successful access, delivery of the device and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, and freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; AND\n* Intended performance of the prosthetic heart valve (no severe prosthesis-patient mismatch and mean aortic valve gradient \\\u003C20 mmHg or peak velocity \\\u003C3 m\u002Fs, Doppler velocity index ≥0.25, and no moderate or severe prosthetic valve regurgitation).\n\nSevere prosthesis-patient mismatch is defined as an indexed effective orifice area (EOAi) ≤0.65 cm²\u002Fm² (≤0.55 cm²\u002Fm² if BMI ≥30 kg\u002Fm²).","30 days post transcatheter valve implantation",[14,18],{"measure":15,"description":16,"timeFrame":17},"Composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems","Safety endpoint","1 year post transcatheter valve implantation",{"measure":19,"description":20,"timeFrame":12},"Moderate or severe prosthesis-patient mismatch","Moderate or severe prosthesis-patient mismatch is defined as EOAi ≤0.85 cm²\u002Fm² (≤0.70 cm²\u002Fm² if BMI ≥30 kg\u002Fm²). This endpoint will be compared between patients treated with the SAPIEN and MYVAL THV series.",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":21,"whoMasked":21},"NONE",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"EVOLUT R\u002FPRO\u002FPRO+\u002FFX bioprosthesis","EXPERIMENTAL","Study subjects will receive a self-expanding valve from the EVOLUT THV series (EVOLUT R\u002FPRO\u002FPRO+\u002FFX).",[34],"Device: EVOLUT R\u002FPRO\u002FPRO+\u002FFX bioprosthesis",{"label":36,"type":37,"description":38,"interventionNames":39},"SAPIEN 3\u002FUltra or MYVAL\u002FOctacor\u002FOctapro bioprosthesis","ACTIVE_COMPARATOR","Study subjects will receive a balloon-expandable valve from either the SAPIEN THV series (SAPIEN 3, SAPIEN 3 Ultra) or the MYVAL THV series (Myval Octacor, Myval Octapro).",[40,41],"Device: Edwards Sapien S3\u002FUltra bioprosthesis","Device: MYVAL\u002FOctacor\u002FOctapro bioprosthesis",[43,47,50],{"type":44,"name":30,"description":45,"armGroupLabels":46,"otherNames":21},"DEVICE","To compare EVOLUT R\u002FPRO\u002FPRO+\u002FFX bioprosthesis versus Edwards SAPIEN 3\u002FUltra bioprosthesis or Myval\u002FOctacor\u002F Octapro in failing surgical bioprostheses",[30],{"type":44,"name":48,"description":48,"armGroupLabels":49,"otherNames":21},"Edwards Sapien S3\u002FUltra bioprosthesis",[36],{"type":44,"name":51,"description":51,"armGroupLabels":52,"otherNames":21},"MYVAL\u002FOctacor\u002FOctapro bioprosthesis",[36],[54,58],{"name":55,"affiliation":56,"role":57},"Nicolas Van Mieghem, MD, PhD","Erasmus Medical Centre","PRINCIPAL_INVESTIGATOR",{"name":59,"affiliation":56,"role":57},"Rutger-Jan Nuis, MD, PhD",[61],{"name":59,"role":62,"phone":63,"phoneExt":21,"email":64},"CONTACT","+31614858291","r.nuis@erasmusmc.nl",[66,84,98,115,129,143,156,168,181,194,206,219,233,248],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Cedars Sinai","RECRUITING","Los Angeles","California","90048","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-118.24368,34.05223,{"lat":78,"lon":77},[81,83],{"name":82,"role":62,"phone":21,"phoneExt":21,"email":21},"Raj Makkar, MD",{"name":82,"role":57,"phone":21,"phoneExt":21,"email":21},{"facility":85,"status":68,"city":86,"state":21,"zip":21,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Vienna General Hospital","Vienna","Austria","AT",{"type":75,"coordinates":90},[91,92],16.37208,48.20849,{"lat":92,"lon":91},[95,97],{"name":96,"role":62,"phone":21,"phoneExt":21,"email":21},"Christian Hengstenberg, MD, PhD",{"name":96,"role":57,"phone":21,"phoneExt":21,"email":21},{"facility":99,"status":100,"city":101,"state":21,"zip":21,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"St Paul's and Vancouver General Hospital","NOT_YET_RECRUITING","Vancouver","Canada","CA",{"type":75,"coordinates":105},[106,107],-123.11934,49.24966,{"lat":107,"lon":106},[110,112,113],{"name":111,"role":62,"phone":21,"phoneExt":21,"email":21},"John Webb, MD",{"name":111,"role":57,"phone":21,"phoneExt":21,"email":21},{"name":114,"role":57,"phone":21,"phoneExt":21,"email":21},"David Wood, MD",{"facility":116,"status":100,"city":117,"state":21,"zip":21,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Rigshospitalet","Copenhagen","Denmark","DK",{"type":75,"coordinates":121},[122,123],12.56553,55.67594,{"lat":123,"lon":122},[126,128],{"name":127,"role":62,"phone":21,"phoneExt":21,"email":21},"Lars Sondergaard, MD",{"name":127,"role":57,"phone":21,"phoneExt":21,"email":21},{"facility":130,"status":68,"city":131,"state":21,"zip":21,"country":132,"countryCode":133,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Institut Cœur Poumon","Lille","France","FR",{"type":75,"coordinates":135},[136,137],3.05512,50.63391,{"lat":137,"lon":136},[140,142],{"name":141,"role":62,"phone":21,"phoneExt":21,"email":21},"Eric Van Belle, MD",{"name":141,"role":57,"phone":21,"phoneExt":21,"email":21},{"facility":144,"status":68,"city":145,"state":21,"zip":21,"country":146,"countryCode":147,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, Germany","Düsseldorf","Germany","DE",{"type":75,"coordinates":149},[150,151],6.77927,51.22319,{"lat":151,"lon":150},[154],{"name":155,"role":62,"phone":21,"phoneExt":21,"email":21},"Verena Veulemans, MD PhD",{"facility":157,"status":100,"city":158,"state":21,"zip":21,"country":146,"countryCode":147,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"University Hospital Mainz","Mainz",{"type":75,"coordinates":160},[161,162],8.28008,49.98185,{"lat":162,"lon":161},[165,167],{"name":166,"role":62,"phone":21,"phoneExt":21,"email":21},"Stephan Von Bardeleben, MD",{"name":166,"role":57,"phone":21,"phoneExt":21,"email":21},{"facility":169,"status":68,"city":170,"state":21,"zip":21,"country":171,"countryCode":172,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece","Athens","Greece","GR",{"type":75,"coordinates":174},[175,176],23.72784,37.98376,{"lat":176,"lon":175},[179],{"name":180,"role":62,"phone":21,"phoneExt":21,"email":21},"Ioannis Iakovou, MD PhD",{"facility":182,"status":68,"city":183,"state":21,"zip":21,"country":184,"countryCode":185,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Institute, Brescia, Italy","Brescia","Italy","IT",{"type":75,"coordinates":187},[188,189],10.21472,45.53558,{"lat":189,"lon":188},[192],{"name":193,"role":62,"phone":21,"phoneExt":21,"email":21},"Diego Maffeo, MD PhD",{"facility":195,"status":100,"city":196,"state":21,"zip":21,"country":184,"countryCode":185,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"University Hospital of Padova","Padua",{"type":75,"coordinates":198},[199,200],11.88586,45.40797,{"lat":200,"lon":199},[203,205],{"name":204,"role":62,"phone":21,"phoneExt":21,"email":21},"Giusepe Tarantini, MD",{"name":204,"role":57,"phone":21,"phoneExt":21,"email":21},{"facility":56,"status":68,"city":207,"state":21,"zip":208,"country":209,"countryCode":210,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Rotterdam","3015 GD","Netherlands","NL",{"type":75,"coordinates":212},[213,214],4.47917,51.9225,{"lat":214,"lon":213},[217],{"name":218,"role":62,"phone":63,"phoneExt":21,"email":64},"Rutger-Jan Nuis",{"facility":220,"status":68,"city":221,"state":21,"zip":21,"country":222,"countryCode":223,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Centro Hospitalar de Lisboa Ocidental","Lisbon","Portugal","PT",{"type":75,"coordinates":225},[226,227],-9.1498,38.72509,{"lat":227,"lon":226},[230,232],{"name":231,"role":62,"phone":21,"phoneExt":21,"email":21},"Rui Teles, MD",{"name":231,"role":57,"phone":21,"phoneExt":21,"email":21},{"facility":234,"status":100,"city":235,"state":21,"zip":21,"country":236,"countryCode":237,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"Inselspital, University Hospital","Bern","Switzerland","CH",{"type":75,"coordinates":239},[240,241],7.44744,46.94809,{"lat":241,"lon":240},[244,246],{"name":245,"role":62,"phone":21,"phoneExt":21,"email":21},"Thomas Pilgrim, MD",{"name":247,"role":57,"phone":21,"phoneExt":21,"email":21},"Thomas Pilgrim",{"facility":249,"status":100,"city":250,"state":21,"zip":21,"country":251,"countryCode":252,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"Leeds Teaching Hospitals","Leeds","United Kingdom","UK",{"type":75,"coordinates":254},[255,256],-1.54785,53.79648,{"lat":256,"lon":255},[259,261],{"name":260,"role":62,"phone":21,"phoneExt":21,"email":21},"Daniel Blackman, MD",{"name":260,"role":57,"phone":21,"phoneExt":21,"email":21},{"type":57,"investigatorFullName":218,"investigatorTitle":263,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Dr.",[265],{"name":266,"class":6},"Cedars-Sinai Medical Center","100427212","balloon-vs-self-expanding-transcatheter-valve-for-degenerated-bioprosthesis-100427212",false,"NCT04843072","Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis","Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis. THE BASELINE TRIAL.","BASELINE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Failing surgical aortic bioprosthesis requiring valve replacement and eligible for transfemoral TAVI with balloon expandable or self-expanding platform per heart team consensus based on multi-modality imaging assessment (including echocardiography and multidetector CT).\n* Written informed consent\n\nExclusion Criteria:\n\n* Not eligible for Transfemoral TAVI with EVOLUT, SAPIEN or MYVAL THV series\n* Multi-valve defects requiring intervention\n* Clinically unstable and\u002For inotropic\u002Fvasopressor \u002Fmechanical support.\n* Known mural thrombus in the left ventricle\n* Presence of a mechanical aortic valve\n* History of recent (within 1 month) stroke or TIA","ALL","18 Years",{"count":278,"type":279},600,"ESTIMATED","INTERVENTIONAL",[282],"NA","Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements are performed using a bioprosthesis. Durability of surgical bioprostheses varies according to patient age at the time of implantation, prosthesis type and size, among other factors. TAVI has become an established treatment option for patients with a degenerated surgical aortic bioprosthesis. The time from index surgical aortic valve replacement (SAVR) to bioprosthetic valve degeneration is typically 8-10 years. TAVI in this setting has shown favorable outcomes. Balloon-expandable and self-expanding transcatheter heart valves (THVs) can both be used for the treatment of a degenerated surgical aortic bioprosthesis and have specific advantages and limitations. Valve-in-valve TAVI may be associated with coronary obstruction, THV migration, paravalvular regurgitation, and prosthesis-patient mismatch.\n\nObjective:\n\nTo compare valve-in-valve TAVI with balloon-expandable SAPIEN\u002FMYVAL THV series versus the self-expanding EVOLUT THV series. The primary analysis evaluates device success at 30 days in the primary cohort. Continued enrollment will additionally support a secondary comparison of the safety and efficacy of the SAPIEN and MYVAL THV series.\n\nStudy design: International multicenter randomized study with 1:1 randomization to TAVI with the EVOLUT THV series or the SAPIEN\u002FMYVAL THV series.\n\nStudy population:\n\nThe primary cohort comprises 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) selected for transfemoral TAVI by heart-team consensus. Enrollment of the primary cohort has been completed.\n\nThe continued-enrollment cohort comprises 160 additional patients and will increase the total study population to 600 patients, with a target distribution of 300 patients treated with the EVOLUT THV series, 150 with the SAPIEN THV series, and 150 with the MYVAL THV series.\n\nInvestigational intervention:\n\nTransfemoral valve-in-valve TAVI with a balloon-expandable SAPIEN or MYVAL THV series or a self-expanding EVOLUT THV series.\n\nMain study parameters\u002Fendpoints:\n\n1. Primary endpoint is device success at 30 days\n\n   Defined by:\n   * Absence of procedural mortality; AND\n   * Technical success at exit from the procedure room defined as freedom from mortality, successful access, delivery of the device and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, and freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; AND\n   * Intended performance of the prosthetic heart valve (no severe prosthesis-patient mismatch and mean aortic valve gradient \\\u003C20 mmHg or peak velocity \\\u003C3 m\u002Fs, Doppler velocity index ≥0.25, and no moderate or severe prosthetic valve regurgitation).\n\n   Severe prosthesis-patient mismatch is defined as an indexed effective orifice area (EOAi) ≤0.65 cm²\u002Fm² (≤0.55 cm²\u002Fm² if BMI ≥30 kg\u002Fm²).\n2. Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure, or valve-related problems.\n3. Secondary objective is comparison of the safety and efficacy of the SAPIEN versus MYVAL THV series, including the incidence of moderate or severe prosthesis-patient mismatch.\n\nThe continued-enrollment cohort is designed to support this comparison.",[285],"Valve Heart Disease","2026-10-07",{"date":288,"type":289},"2026-10-13","ACTUAL",{"date":291,"type":289},"2021-05-01",{"date":293,"type":279},"2029-05-01",{"name":5,"class":6},14]