[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"symptomatic-patients-who-have-had-transcatheter-heart-valve-thv-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:symptomatic-patients-who-have-had-transcatheter-heart-valve-thv-failure":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100485467","the-retavi-prospective-observational-registry-100485467",false,"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.","ALL","18 Years",{"count":19,"type":20},250,"ESTIMATED","5 Years","OBSERVATIONAL","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.",[25,26,27,28,29],"Structural Valve Deterioration","Structural Valve Degeneration","Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure","Prosthetic Valve Malfunction","Prosthesis Failure",[31,25,32,33,34,35,36,37],"Transcatheter Aortic Valve Implantation (TAVI)","redo-TAVI","THV-in-THV","TAV-in-TAV","TAVR-in-TAVR","Redo-TAVR","Revalve","RECRUITING","2025-08-14",{"date":41,"type":42},"2025-08-20","ACTUAL",{"date":44,"type":42},"2023-09-05",{"date":46,"type":20},"2031-12",{"name":48,"class":49},"Institut für Pharmakologie und Präventive Medizin","NETWORK",62,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100546851","randomized-evaluation-for-failed-tavr-100546851","NCT06400342","Randomized Evaluation for Failed TAVR","Randomized Evaluation of Valve-In-Valve Versus Explantation for Failed TAVR (REVIVE-TAVR)","REVIVE-TAVR","Inclusion Criteria:\n\n* Heart Team has confirmed eligibility for both TAVR-explant and redo-TAVR for failed THV\n* Subject is symptomatic from their failed THV, as demonstrated by NYHA Functional Class ≥II\n* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits\n* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.\n\nExclusion Criteria:\n\n* Ongoing sepsis, including active endocarditis;\n* Severe dementia (resulting in either inability to provide informed consent for the trial\u002Fprocedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);\n* Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;\n* Pregnancy or intent to become pregnant for the next 12 months;\n\nCoronary obstruction risk:\n\n\\- Patients at risk of coronary obstruction may be enrolled into the randomized cohort if the operators determine that redo-TAVR can be safely accomplished with leaflet modification or other coronary protection strategies.","100 Years",{"count":61,"type":20},264,"INTERVENTIONAL",[64],"NA","REVIVE TAVR is an acronym for the Randomized Evaluation of Valve-In-Valve versus Explantation for failed TAVR. This is a prospective, multicenter, global randomized trial investigating the safety and efficacy of reintervention for transcatheter heart valve (THV) failure by comparing redo-TAVR (TAV-in-TAV) with TAVR surgical explantation (TAVR-explant) in subjects who are suitable for both options in a real-world clinical setting",[27,28,29],"NOT_YET_RECRUITING","2025-01-21",{"date":70,"type":42},"2025-01-24",{"date":72,"type":20},"2025-03-01",{"date":74,"type":20},"2036-05-01",{"name":76,"class":77},"Medstar Health Research Institute","OTHER"]