Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves

Safety and Effectiveness of Prizvalve Transcatheter Aortic Valve in Patients With Failing Bioprosthetic Valves

The objective of this study is to evaluate the safety and effectiveness of the Prizvalve transcatheter aortic valve in subjects who are at high or greater risk with failing bioprosthetic valves.

Prospective, single arm, multicenter study

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation:

1. Age≥18 years old;
2. Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
3. NYHA Function Class≥ II;
4. Patient who is anatomically suitable for the implantation of the Prizvalve®;
5. According to heart team , patient is at high or greater surgical risk or not suitable for redo open heart surgery of valve replacement;
6. Patient understands the purpose of the trial and volunteers to participate in, sign the informed consent form and is willing to accept relevant examinations and clinical follow-ups.

Exclusion Criteria:

1. Moderate or greater paravalvular regurgitation of the degenerated bioprosthetic valve；
2. Degenerated valve that cannot be securely fixed within the native annulus or exhibits structural incompleteness；
3. Anatomical features deemed unsuitable for transcatheter implantation.
4. Anatomical features that significantly increase the risk of left ventricular outflow tract (LVOT) obstruction；
5. Acute myocardial infarction within 30 days prior to enrollment；
6. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation；
7. Active infective endocarditis or any other active infection；
8. Severe right ventricular dysfunction or severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20 %；
9. Inability to tolerate anticoagulant or antiplatelet therapy；
10. Cerebrovascular accident within 3 months prior to enrollment, excluding transient ischemic attack；
11. Refusal to undergo emergency cardiac surgery under any circumstances；
12. Participation in another drug or device clinical trial that has not yet reached its primary endpoint as of the time of enrollment；
13. Investigator-assessed poor compliance that would preclude adherence to protocol requirements；