[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624771":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":25,"locations":40,"responsibleParty":63,"collaborators":66,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":25,"enrollmentInfo":82,"targetDuration":25,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":93,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Cedars-Sinai Medical Center","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Transcatheter Aortic Valve Replacement TAVR","percutaneous approach as modality of treatment",[12],"Procedure: Transcatheter Aortic Valve Replacement",{"label":14,"type":15,"description":16,"interventionNames":17},"Surgical Aortic Valve Replacement SAVR","ACTIVE_COMPARATOR","open chest approach as modality of treatment",[18],"Procedure: the open chest surgery to replace the aortic valve",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Transcatheter Aortic Valve Replacement","This is a transcatheter, percutaneous approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"the open chest surgery to replace the aortic valve","This is the open chest surgical approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve",[14],[31,34,37],{"name":32,"affiliation":5,"role":33},"Raj Makkar, MD","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Marcio Diniz, PhD","Icahn School of Medicine at Mount Sinai",{"name":38,"affiliation":39,"role":33},"Vinod Thourani, MD","Emory University",[41],{"facility":5,"status":25,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Los Angeles","California","90048","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-118.24368,34.05223,{"lat":51,"lon":50},[54,59],{"name":55,"role":56,"phone":57,"phoneExt":25,"email":58},"Mitch Gheorghiu, MD","CONTACT","310-423-6152","mitch.gheorghiu@cshs.org",{"name":60,"role":56,"phone":61,"phoneExt":25,"email":62},"Khaled Alsabaawi, MD","310-423-6226","khaled.alsaabawi@cshs.org",{"type":33,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Raj Makkar","Principal Investigator",[67,69,70],{"name":68,"class":6},"Patient-Centered Outcomes Research Institute",{"name":36,"class":6},{"name":71,"class":6},"Institut universitaire de cardiologie et de pneumologie de Québec, University Laval","100624771","tavr-vs-savr-in-severe-bicuspid-aortic-stenosis-100624771",false,"NCT07413965","TAVR vs SAVR in Severe Bicuspid Aortic Stenosis","Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr VERsus Surgery (BELIEVERS) Trial","BELIEVERS","Inclusion Criteria:\n\n1. 50 years of age or older at time of consent\n2. Severe AS deemed suitable for a bioprosthesis by a local heart team (unsuitable or patient declined a mechanical valve or Ross procedure, following demonstration of evidence-based shared decision making with a validated decision-aid(1)\n3. Gated contrast CT available and suitable for core laboratory analysis;\n4. BAV anatomy confirmed by CT core laboratory analysis\n\nExclusion Criteria:\n\n1. Recent cardiovascular intervention within 30 days prior to randomization.\n2. Presence of an existing TAVR or SAVR device\n3. Pregnancy or lactation\n4. Extreme or prohibitive TAVR or SAVR risk, adjudicated by Patient Selection Committee (PSC) Review\n5. Active enrollment in another investigational study\n6. Disproportionate TAVR vs SAVR risk, as adjudicated by the patient selection committee\n7. Associated aortopathy (AA≥45mm by maximal cross-sectional dimension, as confirmed by CT core laboratory analysis, or AA\\\u003C45mm but site plan for surgery of the aorta in the event of randomization to surgery\n8. Site plan for treatment of concomitant non-coronary cardiovascular disease in the event of randomization to surgery (for instance, concomitant valve surgery, septal defect or coarctation repair, aorta or root replacement or repair)\n9. In the presence of coronary artery disease deemed necessary for revascularization in the event of randomization to SAVR or TAVR, Syntax score ≥ 32 or deemed unsuitable for PCI, or deemed unsuitable for coronary artery bypass grafting (CABG)\n10. Plan to use any device other than commercially approved Edwards balloon expandable or Medtronic self-expanding TAVR\n11. Leukopenia (WBC \\\u003C 3000 cells\u002FµL), anemia (Hgb \\\u003C 8 g\u002FdL), Thrombocytopenia (Plt \\\u003C 50,000 cells\u002FµL) on latest available labs within 30 days prior to randomization\n12. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days prior to randomization\n13. LVEF \\\u003C 25% within 90 days prior to randomization\n14. Stroke or transient ischemic attack (TIA) within 90 days prior to randomization\n15. Renal insufficiency (eGFR \\\u003C 30 ml\u002Fmin per the Cockcroft-Gault formula)\n16. Severe lung disease (FEV1 \\\u003C 50% predicted), unresolved prior to randomization\n17. History of liver disease defined as MELD Score ≥ 10 or Child-Pugh Class B or C\n18. Unable to complete the KCCQ due cognitive impairment or other medical condition","ALL","50 Years",{"count":83,"type":84},1200,"ESTIMATED","INTERVENTIONAL",[87],"NA","The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).\n\nThe two primary comparators in this study are: Transcatheter Aortic Valve Replacement (TAVR), and Surgical Aortic Valve Replacement (SAVR).\n\nTAVR is a minimally invasive transcatheter procedure to treat aortic valve disease..\n\nSAVR is involving the open chest surgery to replace the aortic valve.\n\nThe devices and international procedures in this Trial (TAVR or SAVR) are commercially approved by the FDA.\n\nConsented patients who are qualifying for the Trial will be randomized 1:1, meaning they will have an equal chance to be treated with either TAVR or SAVR procedure.\n\nConsented patients who will not qualify for the randomized part of the study will be followed up clinically in either TAVR or SAVR Registry arms.\n\nThe study objective is to provide evidence to guide patients and their providers on the most appropriate therapy for valve replacement on this particular BAV anatomy.",[90],"Bicuspid Aortic Valve Disease",[92],"Severe Bicuspid Aortic Valve intervention: TAVR vs SAVR","NOT_YET_RECRUITING","2026-05-07",{"date":96,"type":97},"2026-05-12","ACTUAL",{"date":99,"type":84},"2026-06-24",{"date":101,"type":84},"2040-05-10",{"name":5,"class":6},1]