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RECRUITING
NCT06817148
NA

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

Sponsor: Cedars-Sinai Medical Center

View on ClinicalTrials.gov

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 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.

Official title: Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr Versus surgEry-PILOT Trial

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2025-01-31

Completion Date

2037-02-01

Last Updated

2025-02-10

Healthy Volunteers

No

Interventions

PROCEDURE

transcatheter aortic valve replacement (TAVR)

percutaneous transcatheter aortic valve replacement

PROCEDURE

surgical aortic valve replacement (SAVR)

surgical aortic valve replacement

Locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, United States