[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institut für Pharmakologie und Präventive Medizin\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":102},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,68],{"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":47},"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","RECRUITING","2026-07-29",{"date":38,"type":39},"2026-07-30","ACTUAL",{"date":41,"type":39},"2025-09-15",{"date":43,"type":21},"2037-09-30",{"name":45,"class":46},"Institut für Pharmakologie und Präventive Medizin","NETWORK",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100424273","the-defipace-study-100424273","NCT04804748","The DefiPace Study","Safety and Efficacy of Low-energy Electrical Cardioversion With or Without Bi-atrial Pacing in Patients With Post-operative Atrial Fibrillation in a Real World Setting - The DefiPace Study","Defipace","Inclusion Criteria:\n\n* Patient is scheduled to undergo elective open chest cardiac surgery (bypass and \u002F or valve surgery)\n* Patient is at least 18 years old\n* Patient with isolated bypass surgery is at least 70 years old\n* Patient with valve surgery is at least 60 years old\n* Patient provides written informed consent prior to the procedure\n* Phase B only: patient is scheduled for TMA implantation during the elective cardiac surgery and is potentially eligible for DefiPace use\n\nExclusion Criteria:\n\n* Clinical history of either permanent, persistend or paroxysmal atrial fibrillation\n* Permanent pacemaker\u002Fdefibrillator, other intra-cardiac active implanted electronic devices\n* Minimally-invasive surgery\n* Recent stroke within the last 3 months\n* A history of or current endocarditis\n* Pregnacy at the time of surgery",{"count":57,"type":21},450,"Prospective, non-interventional, multi-center, international registry in two phases in consecutive patients undergoing elective cardiac surgery.\n\nThe DefiPace registry is designed in two phases\n\n1. to document the standard of care in 50 patients with atrial fibrillation (AF)\n2. to assess the treatment and outcomes of patients with post-operative atrial fibrilllation using low-energy cardioversion and subsequent bi-atrial pacing in clinical practice in 100 patients",[60],"Post-operative Atrial Fibrillation POAF",{"date":38,"type":39},{"date":63,"type":39},"2023-03-28",{"date":65,"type":21},"2027-12-31",{"name":45,"class":46},10,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":77,"studyType":22,"phases":4,"briefSummary":78,"conditions":79,"keywords":85,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100485467","the-retavi-prospective-observational-registry-100485467","NCT05601453","The ReTAVI Prospective Observational Registry","Evaluation of Clinical Outcomes of Patients Undergoing a Redo-TAVI Procedure; a Multicenter Prospective Observational Registry","Inclusion Criteria:\n\nConsecutive patients fulfilling the following criteria:\n\n1. Consenting adult patient (≥18 years)\n2. Procedural success of the first TAVI\n3. TAVI device failure of the index THV, irrespective of SVD severity\n4. Intention to treat the patient with a redo-TAVI procedure (SAPIEN family THV)\n5. The Local Heart Team and the Case Review Board consider the patient suitable and indicated for elective redo-TAVI\n6. Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits taking place in the hospital)\n\nExclusion Criteria:\n\n1. Patients without signed informed consent \u002F data protection statement (according to requirements of local IRB\u002FIEC)\n2. Life expectancy below 12 months\n3. Patients with largely incomplete data with respect to the aims of the project\n4. Pregnant women at the time of the redo-TAVI\n\nNote: For all patients included a defined core data set will be collected prospectively. All patients being in accordance with above stated inclusion and exclusion criteria and receiving a balloon-expandable transcatheter aortic valve will be included in the extended documentation.",{"count":76,"type":21},250,"5 Years","Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \\& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure.\n\nThe evidence on redo-TAVI (where a transcatheter heart valve \\[THV\\] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations.\n\nAim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year, 3 years and 5 years.",[80,81,82,83,84],"Structural Valve Deterioration","Structural Valve Degeneration","Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure","Prosthetic Valve Malfunction","Prosthesis Failure",[86,80,87,88,89,90,91,92],"Transcatheter Aortic Valve Implantation (TAVI)","redo-TAVI","THV-in-THV","TAV-in-TAV","TAVR-in-TAVR","Redo-TAVR","Revalve","2025-08-14",{"date":95,"type":39},"2025-08-20",{"date":97,"type":39},"2023-09-05",{"date":99,"type":21},"2031-12",{"name":45,"class":46},62,""]