Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation

• Conditions: Severe Mitral Valve Regurgitation (Disorder)

• 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

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-22
• Primary Completion: 2024-03-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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
Echocardiographic Parameter Changes (Mitral Valve tenting area and height)	5 years	Changes from baseline tenting area and height
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 (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