Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation

Enrolling by invitationOBSERVATIONAL
Enrollment

600

Participants

Timeline

Start Date

June 1, 2017

Primary Completion Date

March 1, 2024

Study Completion Date

December 30, 2025

Conditions
Severe Mitral Valve Regurgitation (Disorder)
Interventions
DEVICE

Trancatheter Edge to Edge Repair

TEER is performed by apposing the edges of the anterior and posterior leaflet (edge-to-edge) of prolapsed MV. The patient may be under conscious sedation or general anesthesia, depending on hospital standard practice. The procedure is performed through femoral venous access and the inter-atrial septum is crossed using standard techniques. Trans-septal puncture allows MitraClip Steerable Guide Catheter (Guide) to advance so that the guide is positioned over the mitral valve. The MitraClip delivery catheter is advanced to the MitraClip device and emerges from the tip of the guide into the left atrium. The MitraClip device can now be opened and advanced through the MV in the LV. Once in the LV, it is pulled back to grasp the leaflets. Two-dimensional and/or 3-dimensional echocardiography and color Doppler are useful for evaluating the anatomical features of the mitral valve and directing the procedure until the double orifice is formed alongside evaluating residual mitral regurgitation

PROCEDURE

Mitral Valve Replacement

Mitral valve replacement is performed using mechanical or biological prosthesis while preserving the subvalvular apparatus to avoid dilation of the left ventricle over time.

PROCEDURE

Restrictive Mitral Annuloplastie

Mitral valve repair consists of a restrictive mitral annuloplasty (RMA) using a prosthetic ring

PROCEDURE

Restrictive Mitral Annuloplastie/Subvalvular Repair

RMA may be associated with the use of a subvalvular repair (SR). The SR permits the approximation or the relocation of papillary muscles which is displaced by post infarction scar formation.

Trial Locations (2)

93200

Francesco Nappi, Saint-Denis

Unknown

Centre Cardiologique Du Nord, Saint-Denis

All Listed Sponsors
collaborator

Campus Bio-Medico University

OTHER

collaborator

Henri Mondor University Hospital

OTHER

collaborator

Hokkaido University

OTHER

collaborator

University of Genova

OTHER

lead

Centre Cardiologique du Nord

OTHER