Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves

NCT ID: NCT07122050

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2029-09-30

Brief Summary

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.

Detailed Description

Prospective, single arm, multicenter study

Conditions

Failing Bioprosthetic Valves

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

105 Failing Mitral Bioprosthetic Valve

Group Type: EXPERIMENTAL

Prizvalve® system Transcatheter valve-in-valve replacement

Intervention Type: DEVICE

Transcatheter valve-in-valve replacement procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted.

At Least 10 Failing Tricuspid Bioprosthetic Valve

Group Type: EXPERIMENTAL

Prizvalve® system Transcatheter valve-in-valve replacement

Intervention Type: DEVICE

Transcatheter valve-in-valve replacement procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted.

At Least 10 Failing Aortic Bioprosthetic Valve

Group Type: EXPERIMENTAL

Prizvalve® system Transcatheter valve-in-valve replacement

Intervention Type: DEVICE

Transcatheter valve-in-valve replacement procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted.

Interventions

Prizvalve® system Transcatheter valve-in-valve replacement

Transcatheter valve-in-valve replacement procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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；

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University

Locations

Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Jian Yang, MD, PhD

Role: CONTACT

yangjian@fmmu.edu.cn

+8613892828016

Meng en Zhai, PhD

Role: CONTACT

zhaimengen@126.com

+8617782801836

Facility Contacts

Jian Yang, MD, PhD

Role: primary

yangjian@fmmu.edu.cn

+8613892828016

Meng en Zhai, PhD

Role: backup

zhaimengen@126.com

+8617782801836

Other Identifiers

Prizvalve-VIV-202504

Identifier Type: -

Identifier Source: org_study_id