NCT07174531

Renato® Transcatheter Valve-in-Valve System Multicenter Registry Trial (China)

Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Renato® Transcatheter Valve-in-Valve System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Beijing Balance Medical Technology Co., Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The Renato® transcatheter valve-in-valve system, developed by Balance Medical, is undergoing a multicenter registry trial across China. The study enrolls patients whose previously implanted surgical or transcatheter bioprosthetic valves have deteriorated and who are at high risk for repeat open-heart surgery. A new bioprosthetic valve is delivered via a transcatheter approach and positioned inside the failing valve, restoring valve function .

Conditions

• Bioprosthesis Failure

Interventions

Type	Name	Description
PROCEDURE	Transcatheter valve in Valve implantation	Transcatheter valve-in-valve implantation for patients with degenerated aortic/mitral/tricuspid bioprosthetic valves who are at high-risk to redo surgical valve replacement.

Timeline

• Start date: 2021-05-25
• Primary completion: 2023-05-20
• Completion: 2023-09-28
• First posted: 2025-09-16
• Last updated: 2025-09-16

Locations

1 site across 1 country: China