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

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 .

Inclusion Criteria:

1. Pre-existing bioprosthetic valve with clinically significant structural deterioration (≥ moderate stenosis or regurgitation) in the mitral, aortic, or tricuspid position, mandating re-intervention.
2. 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:

1. Small true internal diameter of the failing bioprosthesis deemed unsuitable for valve-in-valve therapy by the independent heart-team.
2. 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.
3. Failed tricuspid bioprosthesis with concomitant severe pulmonary hypertension (systolic pulmonary artery pressure > 60 mmHg).
4. Any additional native or prosthetic valve lesion requiring concomitant surgical intervention, as determined by the independent heart-team.
5. More than trivial paravalvular leak around the failing bioprosthesis.
6. Intracardiac thrombus, mass, or vegetation documented by imaging.
7. Myocardial infarction, coronary-stent implantation, cardiac rhythm-device implantation, stroke, or transient ischemic attack within 30 days before screening.
8. Significant coronary artery disease mandating revascularization.
9. Active infective endocarditis within 6 months of screening.
10. Active infection requiring systemic antibiotic therapy at the time of screening.
11. Life expectancy < 12 months for any non-cardiac condition.