TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis (NCT06597188) | Clinical Trial Compass
By InvitationNot Applicable
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
China452 participantsStarted 2025-09-08
Plain-language summary
To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) for the treatment of severe bicuspid aortic valve (BAV) stenosis.
Who can participate
Age range
18 Years – 75 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
. Subject aged ≤ 75 years;
. With symptomatic severe bicuspid aortic stenosis, defined as: peak flow velocity ≥ 4.0m/s, or mean trans-aortic pressure gradient ≥ 40mmHg, or aortic orifice area (AVA) ≤ 1.0cm2 (or AVA index ≤ 0.6cm2/m2) confirmed by echocardiography；
. New York Heart Association (NYHA) cardiac function classification ≥ Class II;
. With an intermediate or low risk of surgical procedures (STS score ≤8%) assessed by the local heart team;
. Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
. Known allergy or resistance to study device and control device components such as nitinol or contrast media;
. Known contraindication or allergy to anticoagulant or antiplatelet medications and inability to tolerate the anticoagulant or antiplatelet therapy;
. Known presence of active infective endocarditis or other active infection;
. Known presence of severe vascular disease that precludes safe implantation of the prosthetic valve;
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
Incidence of composite endpoint events (all-cause mortality, all strokes, and re-hospitalizations [surgery, valve or heart failure related re-hospitalizations])
. Previous prosthetic valve implantation (mechanical or bioprosthetic) in any heart place;
. The aortic root anatomy not suitable for transcatheter aortic valve implantation confirmed by preoperative imaging (including aortic root calcification that influence the sufficient dilatation of the rposthetic valve);
. Intracardiac mass, left ventricular or left atrial thrombus, vegetations confirmed by preoperative echocardiography;