NCT06817148

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis
• Bicuspid Aortic Valve

Interventions

Type	Name	Description
PROCEDURE	transcatheter aortic valve replacement (TAVR)	percutaneous transcatheter aortic valve replacement
PROCEDURE	surgical aortic valve replacement (SAVR)	surgical aortic valve replacement

Timeline

• Start date: 2025-01-31
• Primary completion: 2028-02-01
• Completion: 2037-02-01
• First posted: 2025-02-10
• Last updated: 2025-02-10

Locations

1 site across 1 country: United States