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Randomized Trial of Transcatheter Valve-in-Valve vs Redo Surgery for Bioprosthetic Mitral Dysfunction

NCT04402931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-04

No results posted yet for this study

Summary

Transcatheter valve-in-valve implantation has emerged as a valid alternative to redo surgery for patients with surgical bioprosthetic dysfunction. Nowadays, transcatheter, transeptal mitral valve-in-valve replacement (TsMViV) has been adopted in many centers worldwide. Some studies report low rates of periprocedural morbidity and mortality and favorable hemodynamic parameters of valve performance. However, medium and long-term data on TsMViV as compared to redo surgical mitral valve replacement (rSMVR) is not yet established. Studies of cost-effectiveness and cost-utility comparing both strategies were also not reported. In particular, late prosthesis durability and hemodynamic performance after TsMViV are largely unknown and need to be elucidated before widely indicated, especially among younger and low-risk surgical candidates with failed mitral bioprostheses.

Conditions

  • Mitral Prosthetic Valve Stenosis and Regurgitation

Interventions

PROCEDURE

Transcatheter Valve-in-Valve Intervention

Transcatheter mitral valve-in-valve implantation with SAPIEN 3

PROCEDURE

Redo Mitral valve surgery

Transcatheter Valve-in-Valve Intervention

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Instituto Dante Pazzanese de Cardiologia

    lead OTHER

Principal Investigators

  • Dimytri A Siqueira, MD, PhD · Instituto Dante Pazzanese de Cardiologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-17
Primary Completion
2024-02-01
Completion
2025-08-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04402931 on ClinicalTrials.gov