Status:
COMPLETED
Renato® Transcatheter Valve-in-Valve System Multicenter Registry Trial (China)
Lead Sponsor:
Beijing Balance Medical Technology Co., Ltd
Conditions:
Bioprosthesis Failure
Eligibility:
All Genders
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07174531
Start Date
May 25 2021
End Date
September 28 2023
Last Update
September 16 2025
Active Locations (1)
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1
Balance Medical
Beijing, China