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 range18 Years – 75 Years
SexALL
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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;
✕. Ascending aorta width ≥50mm;
✕. 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);
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])