TAVR vs SAVR in Severe Bicuspid Aortic Stenosis (NCT07413965) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
United States1,200 participantsStarted 2026-04-05
Plain-language summary
The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
The two primary comparators in this study are: Transcatheter Aortic Valve Replacement (TAVR), and Surgical Aortic Valve Replacement (SAVR).
TAVR is a minimally invasive transcatheter procedure to treat aortic valve disease..
SAVR is involving the open chest surgery to replace the aortic valve.
The devices and international procedures in this Trial (TAVR or SAVR) are commercially approved by the FDA.
Consented patients who are qualifying for the Trial will be randomized 1:1, meaning they will have an equal chance to be treated with either TAVR or SAVR procedure.
Consented patients who will not qualify for the randomized part of the study they will be followed up clinically in either TAVR or SAVR Registry arms.
The study objective is to provide evidence to guide patients and their providers on the most appropriate therapy for valve replacement on this particular BAV anatomy.
Who can participate
Age range50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 50 years of age or older at time of consent
✓. Severe AS deemed suitable for a bioprosthesis by a local heart team (unsuitable or patient declined a mechanical valve or Ross procedure, following demonstration of evidence-based shared decision making with a validated decision-aid(1)
✓. Gated contrast CT available and suitable for 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 adjudicated by the patient selection committee
✕
What they're measuring
1
To compare the safety and efficacy of TAVR vs SAVR for the treatment of severe AS in patients with BAV
. Associated aortopathy (AA≥45mm by maximal cross-sectional dimension, as confirmed by CT core laboratory analysis, or AA\<45mm 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)