💬In plain words
What the trial is, and whether it could suit you
This is a prospective, multicenter, randomized controlled clinical study designed to evaluate the real-world performance of the VitaFlow Liberty® Flex Transcatheter Aortic Valve Retrievable and Steerable Delivery System (Investigational Device) for treating severe aortic stenosis (AS) in challenging anatomies. The study will compare it against the VitaFlow Liberty® Retrievable Delivery System (Control Device), which lacks steerability.
Key Study Elements:
Objective: The primary objective is to assess the device's performance using the incidence of a composite endpoint before hospital discharge. This endpoint includes permanent pacemaker implantation (PPI), valve-in-valve (ViV) implantation, or moderate-to-severe paravalvular leakage (PVL).
Design: A prospective, multicenter RCT with 1:1 randomization (Experimental: VitaFlow Liberty® Flex vs. Control: VitaFlow Liberty®). Approximately
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Diagnosis of severe aortic stenosis, defined as: echocardiographically confirmed peak aortic valve velocity ≥4.0 m/s, or mean aortic valve gradient ≥40 mmHg, or aortic valve area (AVA) ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2);
2. Preoperative cardiac and great vessel CT angiography (CTA) with 3D reconstruction demonstrating an aortic-left ventricular angle \>60°, indicating potential challenges for arch crossing and valve crossing;
3. New York Heart Association (NYHA) functional class ≥II;
4. Voluntary participation in the study with signed informed consent.
Exclusion Criteria:
1. Known allergy or intolerance to components of the investigational or control devices (e.g., nitinol) or contrast agents;
2. Contraindication or known allergy to anticoagulant or antiplatelet therapy, rendering the patient unable to tolerate such treatment;
3. Known active infective endocarditis or other active infections;
4. Known severe vascular disease that would preclude safe prosthetic valve implantation;
5. Ascending aorta width ≥55mm;
6. Pre-procedural imaging shows aortic root anatomy unsuitable for transcatheter aortic valve implantation (including aortic root calcification that may affect proper valve expansion);
7. Pre-procedural echocardiography shows intracardiac mass, left ventricular or left atrial thrombus, or vegetation;
8. Acute myocardial infarction within 30 days prior to procedure (defined as Q-wave MI or non-Q-wave MI);
9. Concomitant severe mitral or tricuspid regurgitation;
10. Concomitant cardiogenic shock or hemodynamic instability requiring inotropic support, mechanical ventilation, or mechanical cardiac assistance;
11. Concomitant severe left ventricular dysfunction (defined as left ventricular ejection fraction LVEF\<20%);
12. Concomitant hematologic abnormalities defined as leukopenia (WBC count \<3×109/L), thrombocytopenia (platelet count \<30×109/L), history of bleeding diathesis or coagulopathy, or hypercoagulable state;
13. Female subjects known to be pregnant or breastfeeding;
14. Subjects currently participating in or planning to participate in other drug or device clinical studies within 12 months postoperatively; Any other condition that the investigator or heart team deems may hinder the subject's safe participation in the study.
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What it tests
- Transcatheter Aortic Valve Replacement
180 Fenglin Road
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.