Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation
- Conditions
- Severe Mitral Valve Regurgitation (Disorder)
- Interventions
- Procedure: Mitral Valve ReplacementDevice: Trancatheter Edge to Edge RepairProcedure: Restrictive Mitral Annuloplastie/Subvalvular RepairProcedure: Restrictive Mitral Annuloplastie
- Registration Number
- NCT05090540
- Lead Sponsor
- Centre Cardiologique du Nord
- Brief 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
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 600
- 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%
- Pediatric
- Any echocardiographic evidence of structural (chordal or leaflet) mitral-valve disease
- ruptured papillary
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Mitral Valve Replacement Mitral Valve Replacement 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 Transcatheter Edge to Edge Repair Trancatheter Edge to Edge Repair 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. Restrictive Mitral Annuloplastie Plus Subvalvular Repair Restrictive Mitral Annuloplastie/Subvalvular Repair 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 Restrictive Mitral Annuloplasty Restrictive Mitral Annuloplastie 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.
- Primary Outcome Measures
Name Time Method Left Ventricular Reverse Remodelling 5 years The primary end point of the study is the degree of left ventricular reverse remodeling, as assessed by means of the left ventricular end systolic dimension on the basis of transthoracic echocardiography
- Secondary Outcome Measures
Name Time Method Overall Mortality 5 years The secondary endpoint of the study is the evaluation of overall mortality
Cardiac Death 5 years The secondary endpoint of the study is the evaluation of cardiac death
Major Adverse Cardiac or Cerebrovascular Events (MACCE) 5 years Composite of major adverse cardiac or cerebrovascular events (rate of death, stroke, subsequent mitral valve surgery, hospitalization for heart failure, or an increase in New York Heart Association class higher than one), serious adverse events, recurrent mitral regurgitation, quality of life, and rehospitalization.
Echocardiographic Parameter Changes (LVEF) 5 years Changes from baseline parameters including left ventricular ejection fraction
Echocardiographic Parameter Changes (recurrence) 5 years Recurrent moderate-to-severe mitral regurgitation after intervention
Echocardiographic Parameter Changes (LVEDD) 5 years Changes from baseline Left Ventricular End Diastolic Diameter
Echocardiographic Parameter Changes (Mitral Valve tenting area and height) 5 years Changes from baseline tenting area and height
Echocardiographic Parameter Changes (Pulmonary artery systolic pressure) 5 years Changes from baseline pulmonary artery systolic pressure
Echocardiographic Parameter Changes (anteroposterior mitral valve annular diameter) 5 years Changes from baseline anteroposterior mitral valve annular diameter
Echocardiographic Parameter Changes ( interpapillary distance) 5 years Changes from baseline distance between papillary muscles
Trial Locations
- Locations (2)
Francesco Nappi
🇫🇷Saint Denis, France
Centre Cardiologique Du Nord
🇫🇷Saint Denis, France