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Clinical Trials in China / NCT07122050
Starting soon Not applicable

Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves

NCT07122050 · tracked via the Priya Life Science China tracker
Sponsor
Xijing Hospital
Phase
Not applicable
Started
2025-08-15
Last updated
2025-08-14

Condition(s) studied

Failing Bioprosthetic Valves

Investigational drug(s) / intervention(s)

Prizvalve® system Transcatheter valve-in-valve replacement

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University Xi'an Shaanxi

More Xijing Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07122050 on ClinicalTrials.gov ↗ ← All trials in China