[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"structural-valve-deterioration\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:structural-valve-deterioration":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100519907","comparison-of-allegra-vs-sapien-transcatheter-aortic-valves-in-valve-in-valve-indication-100519907",false,"NCT06049654","Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication","Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication","Inclusion Criteria:\n\nPatients meeting ALL the following criteria will be included:\n\n* Patients aged ≥ 18 years.\n* Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area \\\u003C 1.0 cm2) and\u002For severe valve regurgitation.\n* The patient has cardiac symptoms and\u002For deterioration of left ventricular ejection fraction attributable to the aortic valve disease.\n* Heart team decision of VIV procedure.\n* Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year.\n\nExclusion Criteria:\n\nPatients meeting, at least, 1 of the following criteria will be excluded:\n\n* Patients who openly express their refusal to participate in the study.\n* Female patients in gestational age.\n* Presence or suspicious of biological aortic valve thrombosis.\n* Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.\n* Ongoing sepsis and\u002For suspicious or diagnosis of endocarditis.\n* Patients whose life expectancy is \\\u003C 1 year due to non-cardiac comorbid conditions.\n* Medical, social, or psychological conditions that preclude the subject from appropriate consent or adherence to the protocol required follow-up exams.\n* True inner diameter of the prosthetic valve \\> 27 mm.\n* Transfemoral access inadequate to accommodate an 18F sheath.\n* Patients included in other clinical trials (excluding registries).","ALL","18 Years",{"count":19,"type":20},104,"ESTIMATED","INTERVENTIONAL",[23],"NA","The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.",[26,27],"Aortic Valve Stenosis","Structural Valve Deterioration",[29,30,31,32,33],"Valve-In-Valve","Aortic stenosis","Aortic regurgitation","Trans-catheter aortic valve","Degenerated aortic valve","RECRUITING","2026-06-12",{"date":37,"type":38},"2026-06-15","ACTUAL",{"date":40,"type":38},"2024-02-01",{"date":42,"type":20},"2027-11-01",{"name":44,"class":45},"Fundación EPIC","OTHER",11,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"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":55,"type":20},250,"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.",[27,60,61,62,63],"Structural Valve Degeneration","Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure","Prosthetic Valve Malfunction","Prosthesis Failure",[65,27,66,67,68,69,70,71],"Transcatheter Aortic Valve Implantation (TAVI)","redo-TAVI","THV-in-THV","TAV-in-TAV","TAVR-in-TAVR","Redo-TAVR","Revalve","2025-08-14",{"date":74,"type":38},"2025-08-20",{"date":76,"type":38},"2023-09-05",{"date":78,"type":20},"2031-12",{"name":80,"class":81},"Institut für Pharmakologie und Präventive Medizin","NETWORK",62]