Recruiting

Transcatheter vs. Surgery

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT06817148

Conditions

Aortic Valve Stenosis

Bicuspid Aortic Valve

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

transcatheter aortic valve replacement (TAVR)

surgical aortic valve replacement (SAVR)

Study Details

Brief 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.

Conditions

Aortic Valve Stenosis

Bicuspid Aortic Valve

Study ID

NCT06817148

Start date

Jan 31, 2025

Status verified date

Feb, 2025

Completion date

Feb 1, 2037

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 prohibitive TAVR or SAVR risk, determined by site or committee Active enrollment in another investigational study
  • Disproportionate TAVR vs SAVR risk, as determined by treating site or committee
  • Associated aortopathy (AA≥ 45 mm by maximal cross-sectional dimension, as confirmed by CT core laboratory analysis, or AA<45 mm but site plan for surgery of the aorta in the event of randomization to surgery
  • Site plan for treatment of concomitant non-coronary cardiovascular disease in the event of randomization to surgery (for instance, concomitant valve surgery, septal defect or coarctation repair, aorta or root replacement or repair)
  • In the presence of coronary artery disease deemed necessary for revascularization in the event of randomization to SAVR or TAVR, Syntax score ≥ 32 or deemed unsuitable for PCI, or deemed unsuitable for coronary artery bypass grafting (CABG).

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

transcatheter aortic valve replacement (TAVR)

percutaneous transcatheter aortic valve replacement

surgical aortic valve replacement (SAVR)

surgical aortic valve replacement

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 and Locations

Central contacts

Mitch Gheorghiu

310 423-6152mitch.gheorghiu@cshs.org

Khaled Alsabaawi

310 423-6226khaled.alsabaawi@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Mitch Gheorghiu

310-423-6152mitch.gheorghiu@cshs.org

Khaled Alsabaawi

310 423-6226khaled.alsabaawi@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Feb 10, 2025

Last verified

Feb, 2025

Keywords

  • TAVR
  • BAV
  • SAVR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2025-02-10.