Condition: Aortic Valve Stenosis · Bicuspid Aortic Valve · Sponsor: Cedars-Sinai Medical Center
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.
This description comes directly from the study's public registry record.
Mitch Gheorghiu · 310 423-6152 · mitch.gheorghiu@cshs.org
Khaled Alsabaawi · 310 423-6226 · khaled.alsabaawi@cshs.org
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| Cedars-Sinai Medical Center | Los Angeles, California, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06817148