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Bicuspid Aortic Valve Replacement: TAVR vs. Surgery

This study is comparing two common treatments for severe aortic stenosis (a narrowing of the heart's aortic valve) in people who have a bicuspid aortic valve (a heart valve with two flaps instead of the usual three). The treatments are transcatheter aortic valve replacement (TAVR), which is a less invasive procedure, and surgical aortic valve replacement (SAVR), which is open-heart surgery. Researchers want to see which treatment is safer and works better over one year. You might be able to join if you are over 50 years old, have severe aortic stenosis with a bicuspid aortic valve, and your heart team thinks you are suitable for both TAVR and SAVR. The study will look at a combination of outcomes, including death, stroke, needing another valve procedure, and hospital stays.

Study design
This is a randomized study, meaning you would be randomly assigned to receive either TAVR or SAVR. The study plans to enroll 250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year to assess the study's primary outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06817148

Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial

Recruiting
NAAges 50+InterventionalTreatment
Cedars-Sinai Medical Center
~250 participants
Updated 2025-02-10 on ClinicalTrials.gov
What's tested:transcatheter aortic valve replacement (TAVR)surgical aortic valve replacement (SAVR)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
1 year hierarchical composite outcome of death, disabling stroke, non-disabling stroke, valve reintervention, rehospitalization, unfavorable KCCQ (VARC 3)
Measured over 1 year

Conditions

Aortic Valve Stenosis
Bicuspid Aortic Valve

Explore related trials

Aortic Valve StenosisBicuspid Aortic Valve

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Raj Makkar, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Mitch Gheorghiu
[email protected]
310 423-6152
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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).

What this trial measures

  • 1 year hierarchical composite outcome of death, disabling stroke, non-disabling stroke, valve reintervention, rehospitalization, unfavorable KCCQ (VARC 3)1 year

    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.