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Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation
Sponsor: Centre Cardiologique du Nord
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.
Official title: Transcatheter Edge to Edge Mitral Valve Repair Versus Standard Surgical Mitral Valve Operation for Secondadry Mitral Regurgitation
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
OBSERVATIONAL
Enrollment
600
Start Date
2017-06-01
Completion Date
2025-12-30
Last Updated
2025-03-05
Healthy Volunteers
No
Interventions
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
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.
Restrictive Mitral Annuloplastie
Mitral valve repair consists of a restrictive mitral annuloplasty (RMA) using a prosthetic ring
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.
Locations (2)
Francesco Nappi
Saint-Denis, France
Centre Cardiologique Du Nord
Saint-Denis, France