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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-25

Study Completion Date

2023-09-28

Brief Summary

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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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Detailed Description

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Conditions

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Bioprosthesis Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prosthesis Failure Valve Replacement

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

Group Type EXPERIMENTAL

Transcatheter valve in Valve implantation

Intervention Type 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.

Interventions

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Transcatheter 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No