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.

Study Overview

• Status: Not yet recruiting
• Conditions: Failing Bioprosthetic Valves
• Intervention / Treatment: Device: Prizvalve® system Transcatheter valve-in-valve replacement

Detailed Description

Prospective, single arm, multicenter study

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Yang, MD, PhD; Phone Number: +8613892828016; Email: yangjian@fmmu.edu.cn
• Study Contact Backup: Name: Meng en Zhai, PhD; Phone Number: +8617782801836; Email: zhaimengen@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
      • Contact: Jian Yang, MD, PhD; Phone Number: +8613892828016; Email: yangjian@fmmu.edu.cn
      • Contact: Meng en Zhai, PhD; Phone Number: +8617782801836; Email: zhaimengen@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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；

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 105 Failing Mitral Bioprosthetic Valve	Device: 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.
Experimental: At Least 10 Failing Tricuspid Bioprosthetic Valve	Device: 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.
Experimental: At Least 10 Failing Aortic Bioprosthetic Valve	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	The primary end point is the 30 days all-cause mortality	At 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success	Device Success Criteria; Successful vascular access, delivery, deployment and implantation of the study device, with complete removal of the delivery system from the body;; The implanted prosthetic valve achieves the intended haemodynamic performance, defined as the absence of moderate or greater prosthetic valve stenosis or regurgitation.	immediate post-surgical
Procedural success	Procedural Success Criteria; Correct anatomical positioning of the implanted valve;; No intra-operative or immediate post-procedural death (≤ 72 h);; Achievement of the intended therapeutic goal without occurrence of any major intra-operative complication, including but not limited to coronary obstruction, ventricular septal perforation, damage or dysfunction of other native valves, cardiac tamponade, procedure termination, or conversion to open cardiac surgery.	immediate post-surgical
All-cause mortality		At 6 months, 1 year
The incidence of rehospitalization		At 30 days, 6 months, 1 year
The incidence of myocardial infarction		At 30 days, 6 months, 1 year
The incidence of stroke		At 30 days, 6 months, 1 year
The incidence of bleeding		At 30 days, 6 months, 1 year
The incidence of acute kidney injury		At 30 days, 6 months, 1 year
The incidence of permanent pacemaker implantation		At 30 days, 6 months, 1 year
The incidence of vascular and access-related complications		At 30 days, 6 months, 1 year
The incidence of procedure-related complications		At 30 days, 6 months, 1 year
The incidence of valve dysfunction		At 30 days, 6 months, 1 year
The incidence of NYHA functional class improvement	the New York Heart Association to quantify the severity of functional limitation and symptoms attributable to cardiac disease	At 30 days, 6 months, 1 year
The incidence of quality-of-life improvement	By SF-12 Health Survey (Short-Form 12-item Health Survey)	At 30 days, 6 months, 1 year
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)		At 30 days, 6 months, 1 year

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Jian Yang, MD, PhD, Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: July 22, 2025
• First Submitted That Met QC Criteria: August 10, 2025
• First Posted (Actual): August 14, 2025

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Prizvalve Valve in Valve
• Other Study ID Numbers: Prizvalve-VIV-202504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) would not be shared, according to local authority data privacy policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No