Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr VERsus Surgery (BELIEVERS) Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 1,200
- Locations
- 1
- Primary Endpoint
- To compare the safety and effectiveness of TAVR vs SAVR for the treatment of severe AS in patients with BAV
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel assignment
- Primary Purpose
- Treatment
- Masking
- None (open label)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 50 years of age or older at time of consent
- 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)
- Gated contrast CT available and suitable for core laboratory analysis;
- BAV anatomy confirmed by CT core laboratory analysis
Exclusion Criteria
- Recent cardiovascular intervention within 30 days prior to randomization.
- Presence of an existing TAVR or SAVR device
- Pregnancy or lactation
- Extreme or prohibitive TAVR or SAVR risk, adjudicated by Patient Selection Committee (PSC) Review
- Active enrollment in another investigational study
- Disproportionate TAVR vs SAVR risk, as adjudicated by the patient selection committee
- Associated aortopathy (AA≥45mm by maximal cross-sectional dimension, as confirmed by CT core laboratory analysis, or AA<45mm but site plan for surgery of the aorta in the event of randomization to surgery
- 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)
- 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)
- Plan to use any device other than commercially approved Edwards balloon expandable or Medtronic self-expanding TAVR
- Leukopenia (WBC < 3000 cells/µL), anemia (Hgb < 8 g/dL), Thrombocytopenia (Plt < 50,000 cells/µL) on latest available labs within 30 days prior to randomization
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days prior to randomization
- LVEF < 25% within 90 days prior to randomization
- Stroke or transient ischemic attack (TIA) within 90 days prior to randomization
- Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula)
- Severe lung disease (FEV1 < 50% predicted), unresolved prior to randomization
- History of liver disease defined as MELD Score ≥ 10 or Child-Pugh Class B or C
- Unable to complete the KCCQ due cognitive impairment or other medical condition
Arms & Interventions
Transcatheter Aortic Valve Replacement TAVR
percutaneous approach as modality of treatment
Intervention: Transcatheter Aortic Valve Replacement (Procedure)
Surgical Aortic Valve Replacement SAVR
open chest approach as modality of treatment
Intervention: the open chest surgery to replace the aortic valve (Procedure)
Outcomes
Primary Outcomes
To compare the safety and effectiveness of TAVR vs SAVR for the treatment of severe AS in patients with BAV
Time Frame: 2 years post end of enrollment
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\*)
Secondary Outcomes
- Secondary Imaging Endpoints CT(at 2 years post end of enrollment)
- PHQ-9 questionnaire(at 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)
- Time-to-recovery to baseline (QOR-15)(at 2 years post end of enrolment)
- Additional clinical time-to event endpoints(at 2 years post end of enrollment)
- Secondary Imaging Endpoints(at 2 years post end of enrollment)
Investigators
Raj Makkar
Principal Investigator
Cedars-Sinai Medical Center
Study Sites (1)
Identifiers
- NCT ID
- NCT07413965
- Other Study IDs
- BAV2025-4770
Dates
- First Submitted
- (8 months ago)
- First Posted
- (7 months ago)
- Primary Completion
- (in 5 years)
- Study Completion
- (in 13 years)
- Last Verified
- (9 months ago)
- Last updated
- (last month)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- IPD Sharing Plan
- UNDECIDED
- Has Results
- No