TAVR vs. SAVR for Bicuspid Aortic Stenosis

This study is comparing two ways to treat severe aortic stenosis (narrowing of the aortic valve) in people who have a bicuspid aortic valve (a heart valve with two flaps instead of the usual three). The two treatments are Transcatheter Aortic Valve Replacement (TAVR), which is a less invasive procedure, and Surgical Aortic Valve Replacement (SAVR), which is open-chest surgery. Both TAVR and SAVR use commercially approved devices. The study aims to see which procedure is safer and more effective. You might be able to join if you are 50 or older, have severe aortic stenosis, and your heart team believes a bioprosthetic valve is suitable for you. The study plans to enroll 1200 participants.

Study design
This is a multicenter, randomized study, meaning you will have an equal chance of receiving either TAVR or SAVR. It plans to enroll 1200 participants.
What's involved
If you qualify, you will be randomized to either TAVR or SAVR. You will have clinic visits at 30 days, one year, and annually for up to 10 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through clinic visits for up to 10 years after treatment.

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NCT07413965

TAVR vs SAVR in Severe Bicuspid Aortic Stenosis

Recruiting
NAAges 50+InterventionalTreatment
Cedars-Sinai Medical Center
~1,200 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Transcatheter Aortic Valve Replacementthe open chest surgery to replace the aortic valve

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To compare the safety and effectiveness of TAVR vs SAVR for the treatment of severe AS in patients with BAV
Measured over 2 years post end of enrollment
Bicuspid Aortic Valve Disease
1 sites across 1 states
California1
  • 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

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  • To compare the safety and effectiveness of TAVR vs SAVR for the treatment of severe AS in patients with BAV2 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\*)