[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589345":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":28,"locations":38,"responsibleParty":57,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Institut für Pharmakologie und Präventive Medizin","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TAVI Patients",null,"Adult patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve",[13],"Procedure: Transcatheter aortic valve (S3UR) replacement (TAVR)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","Transcatheter aortic valve (S3UR) replacement (TAVR)","Elective transfemoral TAVi procedure with S3UR valve.",[9],[21,25],{"name":22,"affiliation":23,"role":24},"Tanja Rudolph, Prof.","Heart and Diabetes Center North Rhine-Westphalia University Hospital of the Ruhr University Bochum","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Michael Joner, Prof","German Heart Center",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Claudia Lüske, PhD","CONTACT","044718503324","claudia.lueske@ippmed.de",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"Beate Botta, PhD","044718503325","beate.botta@ippmed.de",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Heart and Diabetes Center North Rhine-Westphalia","RECRUITING","Bad Oeynhausen","North Rhine-Westphalia","32545","Germany","DE",{"type":48,"coordinates":49},"Point",[50,51],8.80365,52.20699,{"lat":51,"lon":50},[54],{"name":22,"role":31,"phone":55,"phoneExt":10,"email":56},"05731971276","trudolph@hdz-nrw.de",{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100589345","prospective-long-term-evaluation-of-the-sapien-3-ultra-resilia-valve-100589345",false,"NCT06953206","Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve","SAPIEN Ultra RESILIA Durability EU Registry - The RESOUND-EU Registry","RESOUND-EU","Inclusion criteria:\n\n* Adult patients (≥18 years)\n* Patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve\n* Patient is willing to attend the follow-up visits up to 10 years at the center\n\nExclusion criteria:\n\n* Lack of written informed consent\n* Emergency procedure\n* Pregnancy at time of TAVI\n\nCritieria for long-term observation (1y-10y):\n\n* Technical success at exit from procedure room (VARC-3):\n\n  * Freedom from mortality\n  * Successful access, delivery of the device, and retrieval of the delivery system\n  * Correct positioning of a single prosthetic heart valve into the proper anatomical location\n  * Freedom from surgery or intervention related to the device (excluding permanent pacemaker or PTA and stenting without major bleeding) or to a major vascular or access related, or cardiac structural complication\n* Absence of the following severe procedural and in-hospital complications (VARC-3 definitions):\n\n  * All stroke\n  * Bleeding type 3-4\n  * Myocardial infarction\n  * Need for a second valve\n  * Valve embolization\n  * Coronary obstruction\n  * Annular rupture","ALL","18 Years",{"count":70,"type":71},500,"ESTIMATED","OBSERVATIONAL","Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.",[75,76,77,78],"Transcatheter Aortic Valve Replacement (TAVR)","Aortic-Stenosis","Aortic Insufficiency","Degenerative Valve Disease",[80,81,82,83,84],"TAVR","SAPIEN 3 Ultra RESILIA Valve","S3UR","TAVI","Aortic Stenosis","2026-07-29",{"date":87,"type":88},"2026-07-30","ACTUAL",{"date":90,"type":88},"2025-09-15",{"date":92,"type":71},"2037-09-30",{"name":5,"class":6},1]