Status:
ENROLLING_BY_INVITATION
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
Lead Sponsor:
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Collaborating Sponsors:
West China Hospital
The First Affiliated Hospital of Anhui Medical University
Conditions:
Aortic Stenosis
Bicuspid Aortic Valve (BAV)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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.
Detailed Description
Transcatheter aortic valve replacement (TAVR) has emerged as the first-line treatment for symptomatic severe AS currently, while TAVR for bicuspid aortic valve (BAV) stenosis has not been well demonst...
Eligibility Criteria
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
- 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);
- Intracardiac mass, left ventricular or left atrial thrombus, vegetations confirmed by preoperative echocardiography;
- 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;
- Comorbid with severe mitral or tricuspid regurgitation;
- Comorbid with cardiogenic shock or hemodynamic instability requiring support from positive inotropic agents or mechanical ventilation or mechanical cardiac assistance;
- Comorbid with severe left ventricular dysfunction (defined as left ventricular ejection fraction LVEF \<20%);
- Comorbid with end-stage renal diseases requiring chronic dialysis;
- 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;
- 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);
- Female subjects known to be pregnant or lactating;
- Life expectancy is less than 12 months as assessed by the investigator;
- Subject is participating in or planning to participate in other drug or device clinical studies within 12 months postoperatively;
- Any other condition that, at the discretion of investigator or heart team, may preclude the subject's safe participation in the study.
Key Trial Info
Start Date :
September 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2032
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT06597188
Start Date
September 8 2025
End Date
September 30 2032
Last Update
September 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
WEST CHINA Hospital of Sichuan University
Chengdu, Sichuan, China, 610041