RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-31
Study Completion:2037-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06817148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Male or female, aged \> 50 years of age
  4. * Site-determined severe AS deemed necessary for treatment with SAVR or TAVR
  5. * Gated contrast CT available and suitable for core laboratory analysis
  6. * BAV anatomy confirmed by CT core laboratory analysis
  1. * Recent cardiovascular intervention within the prior 30 days.
  2. * Presence of an existing TAVR or SAVR device
  3. * Pregnancy or lactation
  4. * Extreme or prohibitive TAVR or SAVR risk, determined by site or committee Active enrollment in another investigational study
  5. * Disproportionate TAVR vs SAVR risk, as determined by treating site or committee
  6. * 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
  7. * 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)
  8. * 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).

Contacts and Locations

Study Contact

Mitch Gheorghiu
CONTACT
310 423-6152
mitch.gheorghiu@cshs.org
Khaled Alsabaawi
CONTACT
310 423-6226
khaled.alsabaawi@cshs.org

Principal Investigator

Raj Makkar, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • Raj Makkar, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-31
Study Completion Date2037-02-01

Study Record Updates

Study Start Date2025-01-31
Study Completion Date2037-02-01

Terms related to this study

Keywords Provided by Researchers

  • TAVR
  • BAV
  • SAVR

Additional Relevant MeSH Terms

  • Aortic Valve Stenosis
  • Bicuspid Aortic Valve