NCT04402931View on ClinicalTrials.gov

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

NACompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

February 17, 2020

Primary Completion Date

February 1, 2024

Study Completion Date

August 1, 2025

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

Trial Locations (7)

22240006

Instituto Nacional de Cardiologia, Rio de Janeiro

41745900

Hospital Ana Nery, Salvador

60840285

Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza

88103901

Instituto de Cardiologia de Santa Catarina, São José

04012909

Instituto Dante Pazzanese de Cardiologia, São Paulo

04021001

UNIFESP, São Paulo

05403900

Instituto do Coração (INCOR), São Paulo

Sponsors

Collaborators (1)

Edwards Lifesciences
All Listed Sponsors
collaborator

Edwards Lifesciences

INDUSTRY

lead

Instituto Dante Pazzanese de Cardiologia

OTHER