Polish Transcatheter Transfemoral Mitral Valve-in-Valve Implantation (Mitral ViV) Registry

RecruitingOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

October 17, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

May 31, 2026

Conditions
Mitral InsufficiencyMitral StenosisMitral Stenosis With InsufficiencyHeart FailureBioprosthesis Failure
Interventions
PROCEDURE

Transcatheter mitral valve-in-valve implantation

Transcatheter transfemoral mitral valve-in-valve implantation is an alternative for surgery redo in high-surgical-risk patients with bioprosthetic valve failure. The procedure is performed via femoral vein access. By the transseptal puncture (in the postero-inferior part of the interatrial septum) and balloon septostomy, the bioprosthetic valve is introduced through the degenerative valve into the left ventricle. The valve is expanded in the mitral position during rapid ventricle pacing.

Trial Locations (7)

15-089

RECRUITING

Medical University of Białystok, Bialystok

80-210

RECRUITING

Medical University of Gdańsk, Gdansk

40-055

RECRUITING

Medical University of Silesia, Katowice

90-419

RECRUITING

Medical University of Łódź, Lodz

45-052

RECRUITING

Medical University of Opole, Opole

02-091

RECRUITING

Medical University of Warsaw, Warsaw

04-628

RECRUITING

Institute of Cardiology, Warsaw

All Listed Sponsors
collaborator

National Institute of Cardiology, Warsaw, Poland

OTHER

collaborator

Medical University of Bialystok

OTHER

collaborator

University of Opole

OTHER

collaborator

Medical University of Gdansk

OTHER

collaborator

Medical University of Silesia

OTHER

collaborator

Medical University of Lodz

OTHER

lead

Medical University of Warsaw

OTHER