Status:
RECRUITING
Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the VitaFlow Liberty® Flex Transcatheter Aortic Valve Delivery System for the Treatment of Severe Aortic Stenosis Lesions
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
First Hospital of China Medical University
The Affiliated Hospital of Qingdao University
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 Steera...
Detailed Description
A Prospective, Multicenter, Randomized Controlled Clinical Trial Evaluating the VitaFlow Liberty® Flex Transcatheter Aortic Valve Retrievable and Steerable Delivery System for Severe Aortic Stenosis i...
Eligibility Criteria
Inclusion
- 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);
- 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;
- New York Heart Association (NYHA) functional class ≥II;
- Voluntary participation in the study with signed informed consent.
Exclusion
- Known allergy or intolerance to components of the investigational or control devices (e.g., nitinol) or contrast agents;
- Contraindication or known allergy to anticoagulant or antiplatelet therapy, rendering the patient unable to tolerate such treatment;
- Known active infective endocarditis or other active infections;
- Known severe vascular disease that would preclude safe prosthetic valve implantation;
- Ascending aorta width ≥55mm;
- Pre-procedural imaging shows aortic root anatomy unsuitable for transcatheter aortic valve implantation (including aortic root calcification that may affect proper valve expansion);
- Pre-procedural echocardiography shows intracardiac mass, left ventricular or left atrial thrombus, or vegetation;
- Acute myocardial infarction within 30 days prior to procedure (defined as Q-wave MI or non-Q-wave MI);
- Concomitant severe mitral or tricuspid regurgitation;
- Concomitant cardiogenic shock or hemodynamic instability requiring inotropic support, mechanical ventilation, or mechanical cardiac assistance;
- Concomitant severe left ventricular dysfunction (defined as left ventricular ejection fraction LVEF\<20%);
- 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;
- Female subjects known to be pregnant or breastfeeding;
- 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.
Key Trial Info
Start Date :
July 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT07145463
Start Date
July 30 2025
End Date
December 31 2027
Last Update
August 28 2025
Active Locations (1)
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1
180 Fenglin Road
Shanghai, Shanghai Municipality, China, 200032