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 2026-06-24
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 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 range
50 Years
Sex
ALL
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;
. BAV anatomy confirmed by CT core laboratory analysis
Exclusion criteria
. Recent cardiovascular intervention within 30 days prior to randomization.
. Presence of an existing TAVR or SAVR device
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To compare the safety and effectiveness of TAVR vs SAVR for the treatment of severe AS in patients with BAV
. Extreme or prohibitive TAVR or SAVR risk, adjudicated by Patient Selection Committee (PSC) Review
. Active enrollment in another investigational study
. Disproportionate TAVR vs SAVR risk, as adjudicated by the patient selection committee
. 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)