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

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.