Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves

Not Applicable

Not yet recruiting

• Conditions: Failing Bioprosthetic Valves

• Registration Number: NCT07122050
• Lead Sponsor: Xijing Hospital

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

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-08-10
• Last Update Submitted: 2025-08-10
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Start: 2025-08-15
• Primary Completion: 2029-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
All-cause mortality	At 30 days	The primary end point is the 30 days all-cause mortality

Secondary Outcome Measures

Name	Time	Method
Device success	immediate post-surgical	Device Success Criteria; 1. Successful vascular access, delivery, deployment and implantation of the study device, with complete removal of the delivery system from the body; 2. The implanted prosthetic valve achieves the intended haemodynamic performance, defined as the absence of moderate or greater prosthetic valve stenosis or regurgitation.
Procedural success	immediate post-surgical	Procedural Success Criteria; 1. Correct anatomical positioning of the implanted valve; 2. No intra-operative or immediate post-procedural death (≤ 72 h); 3. 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.
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	At 30 days, 6 months, 1 year	the New York Heart Association to quantify the severity of functional limitation and symptoms attributable to cardiac disease
The incidence of quality-of-life improvement	At 30 days, 6 months, 1 year	By SF-12 Health Survey (Short-Form 12-item Health Survey)
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)	At 30 days, 6 months, 1 year

Trial Locations

Locations (1)

Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University; 🇨🇳 Xi'an, Shaanxi, China