NCT07413965|RecruitingDMC
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
BELIEVERS
Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr VERsus Surgery (BELIEVERS) Trial
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BELIEVERS
Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr VERsus Surgery (BELIEVERS) Trial
Sponsor study identifier
interventional
1,200
1 country
1
Study Start
July 23, 2026
Actual (reported)Primary Completion
July 1, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 10, 2040
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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). The two primary comparators in this study are: Transcatheter Aortic Valve Replacement (TAVR), and Surgical Aortic Valve Replacement (SAVR). TAVR is a minimally invasive transcatheter procedure to treat aortic valve disease.. SAVR is involving the open chest surgery to replace the aortic valve. The devices and international procedures in this Trial (TAVR or SAVR) are commercially approved by the FDA. Consented 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. Consented patients who will not qualify for the randomized part of the study will be followed up clinically in either TAVR or SAVR Registry arms. The 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 10, 2040
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 30, 2026
Actual (reported)February 17, 2026
Actual (reported)July 23, 2026
Actual (reported)July 1, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 10, 2040
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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: 1. death, 2. disabling stroke, 3. non-disabling stroke, 4. valve reintervention, 5. rehospitalization†, 6. unfavorable KCCQ (VARC-3\*)
2 years post end of enrollment
Time-averaged KCCQ
3 years post end of enrollment
KCCQ status (serial)
at 2 years post end of enrollment
SF-12 questionnaire
at 2 years post end of enrollment
NYHA class
at 2 years post end of enrollment
6-minute walk test
at 2 years post end of enrollment
percutaneous approach as modality of treatment
open chest approach as modality of treatment
This is a transcatheter, percutaneous approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve
This is the open chest surgical approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Raj Makkar, MD
Cedars-Sinai Medical Center
Marcio Diniz, PhD
Icahn School of Medicine at Mount Sinai
Vinod Thourani, MD
Emory University
First Submitted
January 30, 2026
First Posted
February 17, 2026
Whole Exome Sequencing in Bicuspid Aortic Valve Patients
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
July 23, 2026
Actual (reported)Primary Completion
July 1, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 10, 2040
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 14, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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