Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr Versus surgEry-PILOT Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Mitch Gheorghiu
mitch.gheorghiu@cshs.org
310 423-6152
Backup
Khaled Alsabaawi
khaled.alsabaawi@cshs.org
310 423-6226
Time Frame
Start Date: 2025-01-31
Estimated Completion Date: 2037-02-01
Participants
Target number of participants: 250
Treatments
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
Sponsors
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov