Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Failing Bioprosthetic Valves

Treatments: Device: Prizvalve® system Transcatheter valve-in-valve replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT07122050

Prizvalve-VIV-202504

Details and patient eligibility

About

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.

Full description

Prospective, single arm, multicenter study

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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；

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 3 patient groups

105 Failing Mitral Bioprosthetic Valve

Experimental group

Treatment:

Device: Prizvalve® system Transcatheter valve-in-valve replacement

At Least 10 Failing Tricuspid Bioprosthetic Valve

Experimental group

Treatment:

Device: Prizvalve® system Transcatheter valve-in-valve replacement

At Least 10 Failing Aortic Bioprosthetic Valve

Experimental group

Treatment:

Device: Prizvalve® system Transcatheter valve-in-valve replacement