MedTrace Logo

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

NCT07174531 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Beijing Balance Medical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2023-05-20
Completion
2023-09-28

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07174531 on ClinicalTrials.gov