[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"degenerative-valve-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:degenerative-valve-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"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":20,"type":21},500,"ESTIMATED","OBSERVATIONAL","Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.",[25,26,27,28],"Transcatheter Aortic Valve Replacement (TAVR)","Aortic-Stenosis","Aortic Insufficiency","Degenerative Valve Disease",[30,31,32,33,34],"TAVR","SAPIEN 3 Ultra RESILIA Valve","S3UR","TAVI","Aortic Stenosis","NOT_YET_RECRUITING","2026-03-25",{"date":38,"type":39},"2026-03-30","ACTUAL",{"date":41,"type":21},"2026-03-01",{"date":43,"type":21},"2037-09-30",{"name":45,"class":46},"Institut für Pharmakologie und Präventive Medizin","NETWORK"]