Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation

Summary

The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER). The key question of this study is to establish the difference in left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-systolic dimension(LVESD), all-cause and cause-specific (cardiac vs noncardiac) mortality in patients who received the TEER vs the standard surgical procedure for SMR.

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.

Sponsors & Collaborators

• Campus Bio-Medico University

  collaborator OTHER

• Henri Mondor University Hospital

  collaborator OTHER

• Hokkaido University

  collaborator OTHER

• University of Genova

  collaborator OTHER

• Centre Cardiologique du Nord

  lead OTHER

Principal Investigators

• Francesco Nappi, MD · Centre Cardiologique du Nord

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-01

Primary Completion

2024-03-01

Completion

2026-12-30

Countries

• France

Study Locations