Actively Recruiting
Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial
Led by Cedars-Sinai Medical Center · Updated on 2025-02-10
250
Participants Needed
1
Research Sites
626 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Male or female, age greater than 50 years
- Severe aortic stenosis determined by site to need treatment with SAVR or TAVR
- Suitable gated contrast CT scan available for core laboratory analysis
- Bicuspid aortic valve anatomy confirmed by CT core laboratory analysis
You will not qualify if you...
- Cardiovascular intervention within 30 days prior to screening
- Presence of an existing TAVR or SAVR device
- Pregnancy or lactation
- Extreme or prohibitive risk for TAVR or SAVR as determined by site or committee
- Enrollment in another investigational study
- Disproportionate risk between TAVR and SAVR as judged by site or committee
- Aortopathy with maximal aortic dimension 45 mm or more, or planned aortic surgery if randomized to surgery
- Planned surgery for other non-coronary cardiovascular diseases if randomized to surgery
- Coronary artery disease requiring revascularization with Syntax score 32 or above, or unsuitable for PCI or CABG
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
M
Mitch Gheorghiu
CONTACT
K
Khaled Alsabaawi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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