Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves

Prospective, single arm, multicenter study

Inclusion criteria

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

• Age≥18 years old;
• Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
• NYHA Function Class≥ II;
• Patient who is anatomically suitable for the implantation of the Prizvalve®;
• According to heart team , patient is at high or greater surgical risk or not suitable for redo open heart surgery of valve replacement;
• 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

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