Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr Versus surgEry-PILOT Trial
Cedars-Sinai Medical Center
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.
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged \> 50 years of age * Site-determined severe AS deemed necessary for treatment with SAVR or TAVR * Gated contrast CT available and suitable for core laboratory analysis * BAV anatomy confirmed by CT core laboratory analysis Exclusion Criteria: * Recent cardiovascular intervention within the prior 30 days. * Presence of an existing TAVR or SAVR device * Pregnancy or lactation * Extreme or prohib…
Interventions
- Proceduretranscatheter aortic valve replacement (TAVR)
percutaneous transcatheter aortic valve replacement
- Proceduresurgical aortic valve replacement (SAVR)
surgical aortic valve replacement
Location
- Cedars-Sinai Medical CenterLos Angeles, California