Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation (TEERMISO)

Centre Cardiologique du Nord

Status: Invitation-only

Conditions: Severe Mitral Valve Regurgitation (Disorder)

Treatments: Procedure: Mitral Valve Replacement; Procedure: Restrictive Mitral Annuloplastie; Procedure: Restrictive Mitral Annuloplastie/Subvalvular Repair; Device: Trancatheter Edge to Edge Repair

Study type: Observational

Funder types: Other

Identifiers

NCT05090540

CN-21-23 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult
• Ischemic NoIschemic cardiomyopathy
• EROA> 0,2 cm2 or Regurgitant Volume > 30 ml (ESC guidelines).
• EROA ≥ 0.4 cm2 with tethering (ACC/AHA)
• MR Grade 3/4
• Eligible for TEE, surgical repair and replacement of mitral valve
• Coronary artery disease with or without the need for coronary revascularization
• Average value LVEDD 62 mm LVEF 42%

Exclusion criteria

• Pediatric
• Any echocardiographic evidence of structural (chordal or leaflet) mitral-valve disease
• ruptured papillary

Trial design

600 participants in 4 patient groups

Transcatheter Edge to Edge Repair

Description:

TEER procedure is performed by apposing the edges of the anterior and posterior leaflet (edge-to-edge) of MV. If the use of one MitraClip device does not result in sufficient reduction in mitral regurgitation, a second MitraClip device may be used to reduce MR optimizing the procedure.

Treatment:

Device: Trancatheter Edge to Edge Repair

Mitral Valve Replacement

Description:

Mitral-valve replacement includes complete preservation of the subvalvular apparatus to avoid dilation of the left ventricle over time. The technique of preservation, type of prosthetic valve implanted, and technique of suture placement has been chosen according to the preference of the surgeons. In SMR due to ischemic cardiomyopathy, CABG operation(Revascularization) is required

Treatment:

Procedure: Mitral Valve Replacement

Restrictive Mitral Annuloplasty

Description:

RMA may be performed with the use of complete rigid or semi-rigid annuloplasty ring which has been downsized for the annulus diameter. Since patients who received RMA have coronary artery lesions, a CABG operation is useful to ensure favorable remodeling of the left ventricle.

Treatment:

Procedure: Restrictive Mitral Annuloplastie

Restrictive Mitral Annuloplastie Plus Subvalvular Repair

Description:

RMA may be associated with the use of a subvalvular repair (SVR). The SVR permits the approximation or the relocation of papillary muscles which is displaced by post infarction scar formation. In patients who received SVR due to ischemic cardiomyopathy CABG operation is required

Treatment:

Procedure: Restrictive Mitral Annuloplastie/Subvalvular Repair