NCT07122050

Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves

Safety and Effectiveness of Prizvalve Transcatheter Aortic Valve in Patients With Failing Bioprosthetic Valves

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-15
• Primary completion: 2029-09-30
• Completion: 2029-09-30
• First posted: 2025-08-14
• Last updated: 2025-08-14

Locations

1 site across 1 country: China