Bioprosthesis Failure
Conditions
Keywords
Valve-in-Valve, Renato, Aortic Valve Replacement, Tricuspid Valve Replacement, Mitral Valve Replacement
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 .
Interventions
PROCEDURETranscatheter 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
Beijing Balance Medical Technology Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death | 12 months. | Cardiac and non-cardiac mortality will be captured for all enrolled patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Parameters | 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, |
Countries
China
Outcome results
None listed