Bicuspid Aortic Valve DiseaseBELIEVERSNCT07413965
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
A study testing Transcatheter Aortic Valve Replacement and the open chest surgery to replace the aortic valve in people with Bicuspid Aortic Valve Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Bicuspid Aortic Valve Disease
- What is being tested?
- Transcatheter Aortic Valve Replacement and the open chest surgery to replace the aortic valve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2026to 10 May 2040
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mitch Gheorghiu, MD, 310-423-6152, mitch.gheorghiu@cshs.org
Khaled Alsabaawi, MD, 310-423-6226, khaled.alsaabawi@cshs.org
About this study
Official title: Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr VERsus Surgery (BELIEVERS) Trial
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).
Read more
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.
Read the 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.
- Conditions
- Bicuspid Aortic Valve Disease
- Being tested
- Transcatheter Aortic Valve Replacement, the open chest surgery to replace the aortic valve
- Keywords
- Severe Bicuspid Aortic Valve intervention: TAVR vs SAVR
- Medical subject headings
- Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ReplacementProcedure or surgery
This is a transcatheter, percutaneous approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve
the open chest surgery to replace the aortic valveProcedure or surgery
This is the open chest surgical approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Replacement TAVR | Other | percutaneous approach as modality of treatment Receives: Procedure: Transcatheter Aortic Valve Replacement |
| Surgical Aortic Valve Replacement SAVR | Active comparator | open chest approach as modality of treatment Receives: Procedure: the open chest surgery to replace the aortic valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- death,
- disabling stroke,
- non-disabling stroke,
- valve reintervention,
- rehospitalization†,
- unfavorable KCCQ (VARC-3*)
Measured: 2 years post end of enrollment
Secondary outcomes (10)
Time-averaged KCCQ
time-weighted mean of KCCQ overall summary score across at follow-up timepoints
Measured: 3 years post end of enrollment
KCCQ status (serial)
overall summary score at discharge and specified follow-up visits
Measured: at 2 years post end of enrollment
SF-12 questionnaire
physical and mental component summary scores at prespecified visits.
Measured: at 2 years post end of enrollment
NYHA class
NYHA I-IV at prespecified visits
Measured: at 2 years post end of enrollment
6-minute walk test
distance (meters) at prespecified visits.
Measured: at 2 years post end of enrollment
PHQ-9 questionnaire
depression score (0-27) at prespecified visits
Measured: 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).
Measured: 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
Measured: at 2 years post end of enrollment
Secondary Imaging Endpoints
Echocardiography Core Lab• Bioprosthetic valve failure (BVF): • Paravalvular leak (PVL) severity:
Measured: 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.
Measured: at 2 years post end of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start23 Jul 2026
- Primary completion1 Jul 2032 (estimated)
- Study completion10 May 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bicuspid Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The comparator groups are TAVR and SAVR in patients over the age of 50 presenting for a bioprosthesis for severe aortic stenosis and bicuspid aortic valve anatomy. TAVR has shown superiority over SAVR in tricuspid aortic valve (TAV) anatomy in a randomized clinical trial53. However, although TAVR and SAVR have been widely used for BAV, there is to date no randomized trial or even systematic propensity matched data comparing TAVR and SAVR in BAV. The treatments of TAVR and SAVR are standard of care treatments, but the selection of one or the other in bicuspid anatomy remains arbitrary, with no clear framework available for patients and their physicians.
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Icahn School of Medicine at Mount Sinai, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Responsible party
- Principal investigator, Raj Makkar, Cedars-Sinai Medical Center
- Investigators
- Raj Makkar, MD, Principal investigator, Cedars-Sinai Medical CenterMarcio Diniz, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiVinod Thourani, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413965
- Sponsor's protocol ID
- BAV2025-4770
- Acronym
- BELIEVERS
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr VERsus Surgery (BELIEVERS) Trial
- ClinicalTrials.gov ID
- NCT07413965
- Acronym / sponsor ID
- BELIEVERS / BAV2025-4770
- Conditions
- Bicuspid Aortic Valve Disease
- Keywords
- Severe Bicuspid Aortic Valve intervention: TAVR vs SAVR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Icahn School of Medicine at Mount Sinai, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- 1 Jul 2032 (estimated)
- Study completion
- 10 May 2040 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The comparator groups are TAVR and SAVR in patients over the age of 50 presenting for a bioprosthesis for severe aortic stenosis and bicuspid aortic valve anatomy. TAVR has shown superiority over SAVR in tricuspid aortic valve (TAV) anatomy in a randomized clinical trial53. However, although TAVR and SAVR have been widely used for BAV, there is to date no randomized trial or even systematic propensity matched data comparing TAVR and SAVR in BAV. The treatments of TAVR and SAVR are standard of care treatments, but the selection of one or the other in bicuspid anatomy remains arbitrary, with no clear framework available for patients and their physicians.
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Aortic Valve Replacement TAVR | Other | Procedure: Transcatheter Aortic Valve Replacementpercutaneous approach as modality of treatment |
| Surgical Aortic Valve Replacement SAVR | Active comparator | Procedure: the open chest surgery to replace the aortic valveopen chest approach as modality of treatment |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Aortic Valve ReplacementThis is a transcatheter, percutaneous approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve | Procedure or surgery | Transcatheter Aortic Valve Replacement TAVR |
| the open chest surgery to replace the aortic valveThis is the open chest surgical approach using the commercially approved bioprosthetic valve device to replace the diseased aortic valve | Procedure or surgery | Surgical Aortic Valve Replacement SAVR |
Primary outcome
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*)
10 secondary outcomes
Time-averaged KCCQ
Time frame: 3 years post end of enrollment
KCCQ status (serial)
Time frame: at 2 years post end of enrollment
SF-12 questionnaire
Time frame: at 2 years post end of enrollment
NYHA class
Time frame: at 2 years post end of enrollment
6-minute walk test
Time frame: at 2 years post end of enrollment
PHQ-9 questionnaire
Time frame: at 2 years post end of enrollment
Time-to-recovery to baseline (QOR-15)
Time frame: at 2 years post end of enrolment
Additional clinical time-to event endpoints
Time frame: at 2 years post end of enrollment
Secondary Imaging Endpoints
Time frame: at 2 years post end of enrollment
Secondary Imaging Endpoints CT
Time frame: at 2 years post end of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raj Makkar, MD principal investigator
Cedars-Sinai Medical Center
Marcio Diniz, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Vinod Thourani, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve Replacement and the open chest surgery to replace the aortic valve in people with Bicuspid Aortic Valve Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.