Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT06817148
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Valve Stenosis
  • Bicuspid Aortic Valve

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • transcatheter aortic valve replacement (TAVR) — PROCEDURE
    percutaneous transcatheter aortic valve replacement
  • surgical aortic valve replacement (SAVR) — PROCEDURE
    surgical aortic valve replacement

Study Details

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.

Key Dates

Start date
Jan 31, 2025
Status verified
Feb 2025
Primary completion
Feb 1, 2028
Completion
Feb 1, 2037

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: transcatheter aortic valve replacement (TAVR)
    50% of patients will be treated with standard TAVR procedure and followed up for 10 years
  • Active Comparator: surgical aortic valve replacement (SAVR)
    50% of patients will be treated with standard SAVR procedure and followed up for 10 years

Primary Outcome Measure

1 year hierarchical composite outcome of death, disabling stroke, non-disabling stroke, valve reintervention, rehospitalization, unfavorable KCCQ (VARC 3) [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Mitch Gheorghiu
[email protected]
310-423-6152
Khaled Alsabaawi
[email protected]
310 423-6226
Hasan Al-Jilaihawi, MD (SUB_INVESTIGATOR)
Joanna Chikwe, MD (SUB_INVESTIGATOR)
Alfredo Trento, MD (SUB_INVESTIGATOR)
Dominic Emerson, MD (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CA

Related Studies