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
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two standard treatments for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV), a condition where the valve has two leaflets instead of three. This randomized trial compares the safety and effectiveness of transcatheter aortic valve replacement (TAVR), a less invasive procedure, versus surgical aortic valve replacement (SAVR) in patients who are medically suitable for both options. Patients with BAV have been underrepresented in previous studies, so this research aims to provide important information to guide future care. Participants will be randomly assigned to receive either the standard TAVR procedure or the standard SAVR procedure. Each treatment group will be followed for 10 years to monitor outcomes. TAVR is performed through a catheter-based approach, while SAVR involves open-heart surgery. The study includes a long-term follow-up period to assess the lasting effects of each treatment. During the study, patients will undergo routine medical care and evaluations aligned with standard practices. Researchers will track outcomes such as death, stroke, need for valve reintervention, rehospitalization, and quality of life at one year. Additional measures include technical and procedural success at the time of treatment and up to 30 days after. The study aims to follow patients for a total of 10 years to observe long-term results and safety.
CONDITIONS
Brief 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 aged over 50 years
- Severe aortic stenosis requiring treatment with SAVR or TAVR as determined by site
- Availability of gated contrast CT suitable for core lab analysis
- Confirmed bicuspid aortic valve anatomy by CT core lab analysis
You will not qualify if you...
- Cardiovascular intervention within the prior 30 days
- 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
- Active enrollment in another investigational study
- Disproportionate risk favoring one treatment over the other
- Associated aortopathy 45 mm or larger, or planned aortic surgery if randomized to surgery
- Planned treatment of other non-coronary cardiovascular diseases during surgery
- Coronary artery disease requiring revascularization with high Syntax score or unsuitable for PCI or CABG if randomized to TAVR or SAVR
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day and immediate recovery period
Participants undergo either transcatheter or surgical aortic valve replacement procedures.
1 procedure visit (in-person)
Duration - Up to 10 years
Participants are followed up for clinical outcomes and device success after the valve replacement procedure.
Regular follow-up visits for up to 10 years
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
M
Mitch Gheorghiu
K
Khaled Alsabaawi
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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