[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"valve-in-valve-procedures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:valve-in-valve-procedures":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100607877","a-clinical-trial-assessing-the-safety-and-effectiveness-of-the-duravr-thv-system-100607877",false,"NCT07194265","A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System","A Prospective Randomized Trial Assessing the Safety and Effectiveness of the DurAVR® Biomimetic Valve Designed for Physiologic Flow Compared to Commercial TAVR Devices","PARADIGM","Inclusion Criteria:\n\nNative Aortic Stenosis Cohorts:\n\n1. The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System.\n2. The local Heart Team agrees that the subject has an appropriate indication for, and will benefit from, TAVR due to native calcific valve severe aortic stenosis.\n3. Subject understands the study requirements and the treatment procedure and provides written informed consent.\n\nViV Registry Cohort:\n\n1. Severe degeneration of a surgically implanted aortic bioprosthetic valve.\n2. Subject requires aortic valve replacement and is high surgical risk and is indicated for TAVR Valve-in-Valve procedure as determined by the Heart Team.\n3. Subject understands the study requirements and the treatment procedure and provides written informed consent.\n\nExclusion Criteria:\n\nNative Aortic Stenosis Cohorts:\n\n1. Native aortic annulus size unsuitable for study THVs (investigational or control) based on CT imaging analysis.\n2. Access vessel characteristics that would preclude safe placement of the introducer sheath (investigational or control).\n3. Evidence of an acute myocardial infarction 30 days before randomization.\n4. AV is unicuspid, Type 0 bicuspid, or is non-calcified.\n5. Severe total aortic regurgitation\n6. Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis.\n7. Pre-existing mechanical or bioprosthetic valve in any position.\n8. Untreated clinically significant coronary artery disease (CAD) requiring revascularization.\n9. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.\n10. Active bacterial endocarditis in the last 3 months.\n11. Estimated life expectancy (after TAVR) \\\u003C12 months.\n12. Subject is not a candidate for both arms (investigational and control) of the study.\n13. Subject belongs to a vulnerable population\n\nViV Registry Cohort:\n\n1. Anatomy precluding safe placement of DurAVR THV.\n2. Pre-existing prosthetic heart valve in the mitral, tricuspid or pulmonary position.\n3. Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis\n4. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation.\n5. Failing surgical aortic bioprosthesis is unstable, rocking, or not structurally intact.\n6. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.\n7. Untreated clinically significant coronary artery disease (CAD) requiring revascularization.\n8. Need for emergency surgery for any reason\n9. GI bleeding within the past 3 months.\n10. Active bacterial endocarditis in the last 3 months.\n11. Estimated life expectancy (after TAVR) \\\u003C12 months.\n12. Subject belongs to a vulnerable population.","ALL","18 Years",{"count":20,"type":21},1650,"ESTIMATED","INTERVENTIONAL",[24],"NA","Prospective, randomized, controlled, multicenter, international study.\n\nUp to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic Valve Replacement (TAVR), will be enrolled in the 'All Comers Randomized Cohort'. Subjects will be randomized 1:1 to receive either the DurAVR® THV System or any commercially available and approved Transcatheter Heart Valve (THV) from the SAPIEN series or the Evolut series and followed for 10 years.\n\nAfter completion of the All Comers Randomized Cohort, up to 446 additional low-risk subjects will be randomized 1:1 in the 'Low Risk Randomized Continued Access Cohort'.\n\nUp to 150 subjects with a failed surgical bioprosthesis who are deemed high surgical risk and who need valve-in-valve (ViV) TAVR will be enrolled in a separate nested registry (ViV Registry Cohort) and followed for 5 years. Subjects in the ViV Registry Cohort will only receive the DurAVR® THV.",[27,28],"Severe Aortic Stenosis","Valve-in-valve Procedures",[30,31,32],"tavr","severe calcific aortic stenosis","failed surgical bioprosthesis","RECRUITING","2026-07-01",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2025-10-21",{"date":41,"type":21},"2038-03",{"name":43,"class":44},"Anteris Technologies Ltd.","INDUSTRY",8,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100633277","self-expanding-hydra-transcatheter-heart-valve-thv-series-versus-balloon-expandable-devices-for-valve-in-valve-transcatheter-aortic-valve-implantation-tavi-for-patients-with-failed-surgical-aortic-bioprosthesis-100633277","NCT07524595","Self-Expanding Hydra Transcatheter Heart Valve (THV) Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis.","Randomised Comparison of Self-Expanding Hydra THV Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis: REVIVAL Trial","REVIVAL","\"Inclusion Criteria\":\n\n1. Male or Female patient ≥18 years of age\n2. Severe hemodynamic valve deterioration of a surgically implanted bioprosthetic aortic valve, including severe valve stenosis and\u002For severe valve regurgitation, as determined by the Heart Team assessment\n3. Patients eligible for transfemoral TAVI with both study THV platforms per heart team consensus.\n4. TAVI (with or without fracture of surgical valve) is suitable with commercially available sizes of both Hydra and Sapien\u002FMyvall BEVs.\n5. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethics Committee and is willing to comply with all protocol-required (follow-up) evaluations.\n\n\"Exclusion criteria\":\n\n1. Patients unwilling to provide an informed consent, or whose legal representative object to their participation in the study\n2. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in woman of child-bearing potential according to local practice)\n3. Patients with non-transfemoral TAVI access.\n4. Surgical or transcatheter valve in mitral position (mitral rings are not an exclusion)\n5. Patients who had received the Bentall procedure.\n6. Patients with active bacterial endocarditis or ongoing sepsis ≤6 months prior to the index procedure\n7. Echocardiographic evidence of intracardiac mass, thrombus or vegetation\n8. Acute myocardial infarction ≤30 days before the intended TAVI procedure\n9. 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\n10. Patients with severe left ventricular dysfunction and ejection fraction \\\u003C30% or hemodynamic instability requiring inotropic agent or mechanical support.\n11. Patients with significant renal insufficiency (serum creatinine \\>3.0 mg\u002FdL (265.5μmol\u002FL)) and\u002For end stage renal disease requiring chronic dialysis\n12. Patients who are at very high risk of coronary obstruction (e.g., VIVID classification IIB, IIIB, IIIC) and are judged by the heart team to require upfront leaflet laceration (e.g. Basilica or Unicorn procedure) or chimney or snorkel stenting as part of the TAVI procedure.\n13. Any planned surgical or peripheral procedure to be performed in next 30-day after the index procedure\n14. Life expectancy \\\u003C12 months due to non-cardiac co-morbid conditions including carcinomas, chronic liver disease, chronic renal disease or chronic end-stage pulmonary disease",{"count":55,"type":21},111,[24],"This is a prospective, randomised, international, multicentre, open-label, investigator-initiated study in patients undergoing valve-in-valve Transcatheter Aortic Valve Implantation (TAVI) for failed surgical aortic bioprosthesis. A total of 111 patients will be randomized in a 2:1 ratio, with 74 patients assigned to self-expanding Hydra THV Series and 37 patients assigned to BEV (Sapien THV Series and MyVal THV Series).",[59,28,60,61],"AORTIC VALVE DISEASES","Surgical Valve Replacement","Valve Disease, Aortic","NOT_YET_RECRUITING","2026-04-05",{"date":65,"type":37},"2026-04-13",{"date":67,"type":21},"2026-04",{"date":69,"type":21},"2027-08",{"name":71,"class":72},"National University of Ireland, Galway, Ireland","OTHER",1]