NCT07174531

Brief 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 11, 2025

Last Update Submit

September 11, 2025

Conditions

Bioprosthesis Failure

Keywords

Valve-in-ValveRenatoAortic Valve ReplacementTricuspid Valve ReplacementMitral Valve Replacement

Outcome Measures

Primary Outcomes (1)

  • All-cause death

    Cardiac and non-cardiac mortality will be captured for all enrolled patients.

    12 months.

Secondary Outcomes (1)

  • Safety Parameters

    12 months

Study Arms (1)

Prosthesis Failure Valve Replacement

EXPERIMENTAL

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

Procedure: Transcatheter valve in Valve implantation

Interventions

Transcatheter valve in Valve implantationPROCEDURE

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

Prosthesis Failure Valve Replacement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pre-existing bioprosthetic valve with clinically significant structural deterioration (≥ moderate stenosis or regurgitation) in the mitral, aortic, or tricuspid position, mandating re-intervention.
  • Estimated high surgical risk (STS predicted risk of mortality ≥ 8 %) or formal contraindication to redo surgical as confirmed by an independent multidisciplinary heart-team review.

You may not qualify if:

  • Small true internal diameter of the failing bioprosthesis deemed unsuitable for valve-in-valve therapy by the independent heart-team.
  • Failed mitral bioprosthesis with estimated post-procedural left-ventricular outflow tract obstruction (LVOTO) gradient ≥ 30 mmHg or LVOTO risk classified as "high" by the independent heart-team.
  • Failed tricuspid bioprosthesis with concomitant severe pulmonary hypertension (systolic pulmonary artery pressure \> 60 mmHg).
  • Any additional native or prosthetic valve lesion requiring concomitant surgical intervention, as determined by the independent heart-team.
  • More than trivial paravalvular leak around the failing bioprosthesis.
  • Intracardiac thrombus, mass, or vegetation documented by imaging.
  • Myocardial infarction, coronary-stent implantation, cardiac rhythm-device implantation, stroke, or transient ischemic attack within 30 days before screening.
  • Significant coronary artery disease mandating revascularization.
  • Active infective endocarditis within 6 months of screening.
  • Active infection requiring systemic antibiotic therapy at the time of screening.
  • Life expectancy \< 12 months for any non-cardiac condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balance Medical

Beijing, China

Location

Related Publications (1)

  • Chen J, Yang Y, Song W, Feng D, Yan Y, Wang C, Wei L. Transcatheter tricuspid valve-in-valve implantation for degenerated surgical bioprosthesis. Catheter Cardiovasc Interv. 2023 Feb 1;101(2):442-448. doi: 10.1002/ccd.30554. Epub 2023 Jan 8.

    PMID: 36617381BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2025

First Posted

September 16, 2025

Study Start

May 25, 2021

Primary Completion

May 20, 2023

Study Completion

September 28, 2023

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)