Clinical trial NCT06817148: Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial
Official title: Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr Versus surgEry-PILOT Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Bicuspid Aortic Valve
Keywords: TAVR
BAV
SAVR
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: 1 year hierarchical composite outcome of death, disabling stroke, non-disabling stroke, valve reintervention, rehospitalization, unfavorable KCCQ (VARC 3)
timeFrame: 1 year
Secondary outcomes:
measure: Technical success at time of exit from OR/cath lab
timeFrame: exit from procedure (OR or cath lab)
measure: Device success
timeFrame: 30 days
measure: Procedural success
timeFrame: 30 Days
measure: Patient success
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Raj Makkar, MD
role: PRINCIPAL_INVESTIGATOR
References: