Comparing Transcatheter and Surgical Aortic Valve Replacement for Bicuspid Aortic Valve Patients
Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr Versus surgEry-PILOT Trial
This study is testing whether a new heart valve replacement method works better than the traditional surgery for people with severe aortic stenosis and a bicuspid aortic valve.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06817148 on ClinicalTrials.gov |
What this trial studies
This trial is a randomized comparison of two treatment options for severe aortic stenosis in patients with a bicuspid aortic valve. Participants will be assigned to receive either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) after evaluation by a heart team. The study aims to assess the safety and efficacy of these interventions over a follow-up period of 10 years, addressing a gap in previous research regarding patients with bicuspid aortic valve anatomy. The findings may help inform future treatment strategies for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals over 50 years old with severe aortic stenosis and confirmed bicuspid aortic valve anatomy.
Not a fit: Patients with recent cardiovascular interventions, existing valve devices, or those at extreme risk for TAVR or SAVR may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the best treatment options for patients with bicuspid aortic valves suffering from severe aortic stenosis.
How similar studies have performed: While there have been studies on TAVR and SAVR, this specific focus on bicuspid aortic valve patients is relatively novel and under-researched.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Raj Makkar, MD — Cedars-Sinai Medical Center
- Study coordinator: Mitch Gheorghiu
- Email: mitch.gheorghiu@cshs.org
- Phone: 310 423-6152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.