TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06597188, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Trial code
- NCT06597188
- Record updated
- 16 September 2025
- Original description
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.Read full original descriptionShow less
Comparison of Transcatheter Aortic Valve Replacement With Surgical Aortic Valve Replacecment: A Prospective, Multicenter, International, Randomized Controlled, Non-inferiority Study for Bicuspid Aortic Valve Stenosis (PROMIS-BAV)
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.
Inclusion: 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: Previous prosthetic valve implantation (mechanical or bioprosthetic) in any heart place; Acute myocardial infarction (defined as Q-wave MI or non-Q-wave MI) within 30 days prior to surgery; Invasive therapeutic cardiac surgery within 30 days prior to surgery (except for temporary pacemaker or implantable cardioverter-defibrillator implantation); Clinically diagnosed stroke or TIA within 3 months prior to surgery; Gastrointestinal bleeding requiring hospitalization or transfusion therapy or other clinically significant bleeding or coagulation disorders within 3 months prior to surgery, which preclude the required antiplatelet therapy in the study; Comorbid with severe native coronary artery lesions that require revascularization therapy; Subject is participating in or planning to participate in other drug or device clinical studies within 12 months postoperatively; 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; Comorbid with cardiogenic shock or hemodynamic instability requiring support from positive inotropic agents or mechanical ventilation or mechanical cardiac assistance; Comorbid with end-stage renal diseases requiring chronic dialysis; Subjects corresponding to the criteria of a vulnerable population (including patients who are unable to fully understand all aspects of the study, patients lacking capacity in the informed consent procedure and patients with dementia and cognitive impairment); Any other condition that, at the discretion of investigator or heart team, may preclude the subject's safe participation in the study; Comorbid with severe left ventricular dysfunction (defined as left ventricular ejection fraction LVEF <20%); Comorbid with blood dyscrasias defined as leukopenia (white blood cell count < 3×109/L), thrombocytopenia (platelet count < 50×109/L), history of bleeding diathesis or coagulopathy, or hypercoagulable states; Ascending aorta width ≥50mm; 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; Comorbid with severe mitral or tricuspid regurgitation; Female subjects known to be pregnant or lactating; Life expectancy is less than 12 months as assessed by the investigator.