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.
Bicuspid aortic valve is a congenital heart condition characterized by the presence of two, rather than the typical three, cusps in the aortic valve. The 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. The 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. Since 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. The 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,200
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, United States
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\*)
Time frame: 2 years post end of enrollment
Time-averaged KCCQ
time-weighted mean of KCCQ overall summary score across at follow-up timepoints
Time frame: 3 years post end of enrollment
KCCQ status (serial)
overall summary score at discharge and specified follow-up visits
Time frame: at 2 years post end of enrollment
SF-12 questionnaire
physical and mental component summary scores at prespecified visits.
Time frame: at 2 years post end of enrollment
NYHA class
NYHA I-IV at prespecified visits
Time frame: at 2 years post end of enrollment
6-minute walk test
distance (meters) at prespecified visits.
Time frame: at 2 years post end of enrollment
PHQ-9 questionnaire
depression score (0-27) at prespecified visits
Time frame: at 2 years post end of enrollment
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).
Time frame: at 2 years post end of enrolment
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/stroke/rehospitalization: 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
Time frame: at 2 years post end of enrollment
Secondary Imaging Endpoints
Echocardiography Core Lab• Bioprosthetic valve failure (BVF): • Paravalvular leak (PVL) severity:
Time frame: at 2 years post end of enrollment
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/year): annualized change in maximum ascending aorta diameter from baseline to follow-up CT by CT Core Lab.
Time frame: at 2 years post end of enrollment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.