[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07413965":3,"trial-entities:NCT07413965":123,"trial-summary:NCT07413965":128},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":46,"sex":80,"minimum_age":81,"maximum_age":82,"healthy_volunteers":83,"eligibility_criteria":84,"std_ages":88,"locations":91,"central_contacts":110,"overall_officials":111,"references":121,"see_also_links":122},"NCT07413965","BAV2025-4770","TAVR vs SAVR in Severe Bicuspid Aortic Stenosis","Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr VERsus Surgery (BELIEVERS) Trial","RECRUITING","2040-05-10","2026-01","2026-08-14","2026-07-23","Cedars-Sinai Medical Center","OTHER",true,"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.","Bicuspid aortic valve is a congenital heart condition characterized by the presence of two, rather than the typical three, cusps in the aortic valve.\n\nThe condition can lead to various complications, including aortic stenosis (AS; narrowing of the valve opening), aortic regurgitation (leaking of the valve), and an increased risk of aortic aneurysm.\n\nThe BELIEVERS trial builds on this foundation, integrating imaging-guided methodologies to create a robust framework for randomization with contemporary technologies and thus provide definitive evidence for treatment of this complex population.\n\nSince the congenital severe bicuspid aortic valve stenosis was considered in most of the cases an exclusion from all large TAVR vs SAVR trials, there is no clear evidence on which procedure would be more efficient for such anatomical condition.\n\nThe suitable consented subjects will be randomized 1:1 on either TAVR or SAVR arm. These patients will be followed through clinic visits at 30 days, one year and annually up to 10 years.",[19],"Bicuspid Aortic Valve Disease",[21],"Severe Bicuspid Aortic Valve intervention: TAVR vs SAVR","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},1200,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"PROCEDURE","Transcatheter Aortic Valve Replacement","This is a transcatheter, percutaneous approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve",[35],"Transcatheter Aortic Valve Replacement TAVR",{"type":31,"name":37,"description":38,"armGroupLabels":39},"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",[40],"Surgical Aortic Valve Replacement SAVR",[42],{"measure":43,"description":44,"timeFrame":45},"To compare the safety and effectiveness of TAVR vs SAVR for the treatment of severe AS in patients with BAV","A hierarchical composite (assessed by Win ratio at latest available follow-up) of:\n\n1. death,\n2. disabling stroke,\n3. non-disabling stroke,\n4. valve reintervention,\n5. rehospitalization†,\n6. unfavorable KCCQ (VARC-3\\*)","2 years post end of enrollment",[47,51,55,58,61,64,67,71,74,77],{"measure":48,"description":49,"timeFrame":50},"Time-averaged KCCQ","time-weighted mean of KCCQ overall summary score across at follow-up timepoints","3 years post end of enrollment",{"measure":52,"description":53,"timeFrame":54},"KCCQ status (serial)","overall summary score at discharge and specified follow-up visits","at 2 years post end of enrollment",{"measure":56,"description":57,"timeFrame":54},"SF-12 questionnaire","physical and mental component summary scores at prespecified visits.",{"measure":59,"description":60,"timeFrame":54},"NYHA class","NYHA I-IV at prespecified visits",{"measure":62,"description":63,"timeFrame":54},"6-minute walk test","distance (meters) at prespecified visits.",{"measure":65,"description":66,"timeFrame":54},"PHQ-9 questionnaire","depression score (0-27) at prespecified visits",{"measure":68,"description":69,"timeFrame":70},"Time-to-recovery to baseline (QOR-15)","time from index procedure to first follow-up at which QOR-15 returns to (or exceeds) the participant's pre-procedure baseline (operational rules and handling of missingness specified in SAP).","at 2 years post end of enrolment",{"measure":72,"description":73,"timeFrame":54},"Additional clinical time-to event endpoints","death (time-to-first event) and cardiovascular death (time-to-fist event),•All stroke, disabling stroke (time-to-first event). • Rehospitalization (time-to-first event), • Composite of death\u002Fstroke\u002Frehospitalization: time to first occurrence of any of death, any stroke, or qualifying rehospitalization. • Aortic dissection: imaging-, operative-, or autopsy-confirmed aortic dissection after randomization. • Need for surgery of the aorta: • CV rehospitalization days",{"measure":75,"description":76,"timeFrame":54},"Secondary Imaging Endpoints","Echocardiography Core Lab• Bioprosthetic valve failure (BVF): • Paravalvular leak (PVL) severity:",{"measure":78,"description":79,"timeFrame":54},"Secondary Imaging Endpoints CT","Ascending aorta dimension \\>50 mm: maximum ascending aorta diameter measured by CT Core Lab; endpoint met if \\>50 mm at any follow-up CT• Change in ascending aorta dimension (cm\u002Fyear): annualized change in maximum ascending aorta diameter from baseline to follow-up CT by CT Core Lab.","ALL","50 Years",null,false,{"inclusion":85,"exclusion":86,"raw_text":87},[],[],"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",[89,90],"ADULT","OLDER_ADULT",[92],{"facility":13,"status":8,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":107},"Los Angeles","California","90048","United States",[98,103],{"name":99,"role":100,"phone":101,"email":102},"Mitch Gheorghiu, MD","CONTACT","310-423-6152","mitch.gheorghiu@cshs.org",{"name":104,"role":100,"phone":105,"email":106},"Khaled Alsabaawi, MD","310-423-6226","khaled.alsaabawi@cshs.org",{"lat":108,"lon":109},34.05223,-118.24368,[],[112,115,118],{"name":113,"affiliation":13,"role":114},"Raj Makkar, MD","PRINCIPAL_INVESTIGATOR",{"name":116,"affiliation":117,"role":114},"Marcio Diniz, PhD","Icahn School of Medicine at Mount Sinai",{"name":119,"affiliation":120,"role":114},"Vinod Thourani, MD","Emory University",[],[],{"nct_id":4,"conditions":124,"biomarkers":127},[125,126],"Aortic Valve Stenosis","Bicuspid Aortic Valve",[],{"nct_id":4,"found":15,"summary":129,"prompt_version":139},{"design":130,"status":131,"heading":132,"summary":133,"follow_up":134,"word_count":135,"commitments":136,"compensation":137,"drugs_mentioned":138},"This is a multicenter, randomized study, meaning you will have an equal chance of receiving either TAVR or SAVR. It plans to enroll 1200 participants.","completed","TAVR vs. SAVR for Bicuspid Aortic Stenosis","This study is comparing two ways to treat severe aortic stenosis (narrowing of the aortic valve) in people who have a bicuspid aortic valve (a heart valve with two flaps instead of the usual three). The two treatments are Transcatheter Aortic Valve Replacement (TAVR), which is a less invasive procedure, and Surgical Aortic Valve Replacement (SAVR), which is open-chest surgery. Both TAVR and SAVR use commercially approved devices. The study aims to see which procedure is safer and more effective. You might be able to join if you are 50 or older, have severe aortic stenosis, and your heart team believes a bioprosthetic valve is suitable for you. The study plans to enroll 1200 participants.","Participants will be followed through clinic visits for up to 10 years after treatment.",115,"If you qualify, you will be randomized to either TAVR or SAVR. You will have clinic visits at 30 days, one year, and annually for up to 10 years.","Not stated in the trial record.",[32],"v2"]