NCT05090540

Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation

Transcatheter Edge to Edge Mitral Valve Repair Versus Standard Surgical Mitral Valve Operation for Secondadry Mitral Regurgitation

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Centre Cardiologique du Nord · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The target population enrolled in the registry includes patients with moderate to severe secondary mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology who have had TEER or standard surgical procedure of their mitral valves with or without CABG. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, mitral regurgitation, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV. Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement and recipients of mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair. Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement, and those who received mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair

Conditions

• Severe Mitral Valve Regurgitation (Disorder)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-01
• Primary completion: 2024-03-01
• Completion: 2025-12-30
• First posted: 2021-10-22
• Last updated: 2025-03-05

Locations

2 sites across 1 country: France