BELIEVERS
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
AI Description
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.
- Who can join
- adult, older adult
- Participants
- 1200
- Expected completion
- 2040-05-10
- Funded by
- other
Conditions studied
Bicuspid Aortic Valve Disease
What is being tested
- PROCEDURE: Transcatheter Aortic Valve Replacement
- PROCEDURE: the open chest surgery to replace the aortic valve
What it measures
- 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
Working with
Icahn School of Medicine at Mount Sinai, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Patient-Centered Outcomes Research Institute
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2026-08-14
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.