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NCT Number: NCT07174531

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

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 .

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Key information

Conditions

Bioprosthesis Failure

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balance Medical

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Transcatheter valve in Valve implantation

Procedure

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

Primary outcomes

  1. All-cause death

    Time frame: 12 months.

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

Secondary outcomes

  1. Safety Parameters

    Time frame: 12 months

    Incidence of major adverse cardiovascular events (MACE), defined as a composite of myocardial infarction, stroke, permanent pacemaker implantation, or rehospitalization due to heart failure,

Sponsors and collaborators

Lead sponsor

Beijing Balance Medical Technology Co., Ltd

Industry

Registry information

Official study title

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

Acronym: VIV

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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