TAVR vs SAVR in Severe Bicuspid Aortic Stenosis

The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). The two primary comparators in this study are: Transcatheter Aortic Valve Replacement (TAVR), and Surgical Aortic Valve Replacement (SAVR). TAVR is a minimally invasive transcatheter procedure to treat aortic valve disease.. SAVR is involving the open chest surgery to replace the aortic valve. The devices and international procedures in this Trial (TAVR or SAVR) are commercially approved by the FDA. Consented patients who are qualifying for the Trial will be randomized 1:1, meaning they will have an equal chance to be treated with either TAVR or SAVR procedure. Consented patients who will not qualify for the randomized part of the study will be followed up clinically in either TAVR or SAVR Registry arms. The study objective is to provide evidence to guide patients and their providers on the most appropriate therapy for valve replacement on this particular BAV anatomy.

NCT Number	NCT07413965
Lead Sponsor	Cedars-Sinai Medical Center Collaborators: Patient-Centered Outcomes Research Institute, Icahn School of Medicine at Mount Sinai, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Conditions	Bicuspid Aortic Valve Disease
Enrollment	1,200 participants
Start Date	2026-07-23
Primary Completion	2032-07-01 (estimated)
Study Completion	2040-05-10 (estimated)
Updated on ClinicalTrials.gov	2026-08-14