Aortic Valve StenosisBELIEVE-ITNCT06817148
Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial
A study testing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in people with Aortic Valve Stenosis and Bicuspid Aortic Valve, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). Namely, the therapies to which patients will be randomized will be transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), in… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Bicuspid Aortic Valve
- What is being tested?
- transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2025to 1 Feb 2037
- Phase
- Interventional
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
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged > 50 years of age
- Site-determined severe AS deemed necessary for treatment with SAVR or TAVR
- 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 the prior 30 days.
- Presence of an existing TAVR or SAVR device
- Pregnancy or lactation
- Extreme or prohibitive TAVR or SAVR risk, determined by site or committee Active enrollment in another investigational study
- Disproportionate TAVR vs SAVR risk, as determined by treating site or committee
- Associated aortopathy (AA≥ 45 mm by maximal cross-sectional dimension, as confirmed by CT core laboratory analysis, or AA<45 mm 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).
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, 310-423-6152, mitch.gheorghiu@cshs.org
Khaled Alsabaawi, 310 423-6226, khaled.alsabaawi@cshs.org
About this study
Official title: Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr Versus surgEry-PILOT Trial
The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). Namely, the therapies to which patients will be randomized will be transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), in patients deemed clinically suitable for both following heart team review.
The purpose of this study is to compare the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) versus Surgical Aortic Valve Replacement (SAVR) for treating patients with severe aortic stenosis (AS) who have a congenital bicuspid aortic valve (BAV) anatomy. Patients with BAV anatomy have been under-represented in previous trials and this study might provide important information to help guide future treatment options.
The study patients will be followed with standard of care procedures for 10 years.
- Conditions
- Aortic Valve Stenosis, Bicuspid Aortic Valve
- Being tested
- transcatheter aortic valve replacement (TAVR), surgical aortic valve replacement (SAVR)
- Keywords
- TAVR, BAV, SAVR
- Medical subject headings
- Aortic Valve Stenosis, 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 replacement (TAVR)Procedure or surgery
percutaneous transcatheter aortic valve replacement
surgical aortic valve replacement (SAVR)Procedure or surgery
surgical aortic valve replacement
| Study group | Role | What they receive |
|---|---|---|
| transcatheter aortic valve replacement (TAVR) | Active comparator | 50% of patients will be treated with standard TAVR procedure and followed up for 10 years Receives: Procedure: transcatheter aortic valve replacement (TAVR) |
| surgical aortic valve replacement (SAVR) | Active comparator | 50% of patients will be treated with standard SAVR procedure and followed up for 10 years Receives: Procedure: surgical aortic valve replacement (SAVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year hierarchical composite outcome of death, disabling stroke, non-disabling stroke, valve reintervention, rehospitalization, unfavorable KCCQ (VARC 3)
The primary endpoint will be analyzed by the Win ratio method14. That is, every patient in the TAVR group will be compared with every patient in the SAVR group to determine which pair has won. A win higher up in the hierarchy takes priority, so KCCQ gets used only for those pairs that were tied on the first 5 event components. Then KCCQ win is declared if the time-averaged change in KCCQ differs by 5 points or more. The win ratio= total wins on TAVR divided by total wins on SAVR, for which a 95% CI and p value is calculated.
Measured: 1 year
Secondary outcomes (4)
Technical success at time of exit from OR/cath lab
defined as meeting of the following:
- Alive
- Successful access, delivery and retrieval of the device delivery system
- Deployment and correct positioning (including repositioning /recapture if needed) of the single intended valve
- No additional unplanned or emergency surgery or re-intervention prior to leaving OR/Cath lab related to the device or access procedure (includes need for return to bypass post initial wean
Measured: exit from procedure (OR or cath lab)
Device success
Defined as meeting all of the following:
- Alive and stroke-free
- Original intended device in place
- No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/OR)
- Intended performance of the device:
- Structural performance: No migration, embolization, detachment, fracture, or thrombosis
- Hemodynamic performance: Mean gradient < 20mmHg, AVA >1cm2, jet velocity < 3.0 m/s
- Absence of the following para-device complications (PVL > mild, erosion, hemolysis, or endocarditis)
Measured: 30 days
Procedural success
Defined as meeting all of the following:
- Life-threatening bleed (BARC 3b or greater)
- Major vascular or cardiac structural complications requiring unplanned reintervention or surgery
- Stage 2 or 3 AKI (includes new dialysis)
- MI or need for PCI/CABG
- Severe heart failure or hypotension requiring IV inotrope >12 hours, ultrafiltration or mechanical circulatory support
- Prolonged intubation > 48 hours
- Need for a permanent pacemaker implant or continuous, new onset atrial fibrillation
Measured: 30 Days
Patient success
Defined as meeting all of the following:
- Device success
- No re-hospitalizations or re-interventions for the underlying condition (e.g., Aortic stenosis and Heart Failure)
- Return to prior living arrangement (or equivalent)
- Improvement in symptoms defined as increase in NYHA Class > 1 compared to Baseline
- Improvement in functional status defined as 6MWT > 25 m compared to Baseline
- Improvement in quality-of-life defined as KCCQ score > 10 compared to Baseline
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start31 Jan 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raj Makkar, Cedars-Sinai Medical Center
- Investigators
- Raj Makkar, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817148
- Sponsor's protocol ID
- STUDY00003805
- Acronym
- BELIEVE-IT
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No