An interventional study of percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW and cardiac surgery in Mitral Regurgitation, sponsored by Nantes University Hospital. Active, not recruiting at 31 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment
The objective of the study is to demonstrate the non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® in comparison with a surgical treatment strategy in patients with severe primary mitral regurgitation judged eligible for anatomical repair with the MitraClip® or mitral valve surgery with high surgical risk.
This trial is a French and Monegasque, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years ( clinical visit at 1 month, at 6 months and 12 months, phone call at 18 months and clincial visit at 24 months).
Primary Mitral Regurgitation grade 3+ or 4+
Non-inclusion Criteria:
Exclusion criteria
MitraClip NT System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system
Device: percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW
mitral valve repair in first intervention, valve replacement if repair not feasible
Procedure: cardiac surgery
percutaneous mitral valve repair Percutaneous MitraClip Device Implantation
Also known as: MITRACLIP
mitral valve repair or mitral valve remplacement
All-cause mortality, unplanned hospitalizations for heart failure and mitral valve reintervention
comparison between arms of: * number and reason of death * number and reason unplanned rehospitalisation for cardiovascular reasons, * number of mitral valve reintervention
Time frame: 12 months
occurrence of a major adverse event
all-cause death, need for non-elective cardiovascular or thoracic surgery, device or procedure-related adverse events, major bleeding complications or serious bleeding, major access site vascular complications, major cardiac structural complications, pulmonary complications (device or procedure-related), stroke and other cerebrovascular events, myocardial infarction, acute kidney injury or progression of chronic kidney disease, arrhythmias and conduction system disturbances, unplanned mitral valve surgery due to device/procedure failure or malfunction, requirement for valve replacement after valve repair failure, unplanned cardiac surgery for any cause
Time frame: 30 days
Overall rate of surgery related Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) Effects (SADEs)
SAEs et SADEs rate related to protocol procedure all SAEs and SADEs
Time frame: 6, 12 and 24 months
all-cause mortality
Rate of global mortality (all-causes)
Time frame: 30 days and 6, 12 and 24 months
cardiovascular mortality
Rate of cardiovascular mortality
Time frame: 30 days and 6, 12 and 24 months
unplanned heart failure rehospitalization
Rate of unplanned heart failure rehospitalization
Time frame: 6, 12 and 24 months
unplanned rehospitalization rate for cardiovascular reasons
Rate of unplanned rehospitalization for cardiovascular reasons
Time frame: 30 days 6, 12 and 24 months
mitral valve reintervention
Mitral valve reintervention rate
Time frame: 30 days 6, 12 and 24 months
residual MR
MR (Mitral Regurgitation): grade
Time frame: 30 days 6, 12 and 24 months
left and right chamber remodelling and parameters (dimension)
End-systolic dimension End-diastolic dimension Left atrial dimension
Time frame: baseline, 30 days and 12 months
left and right chamber remodelling and parameters (volume)
End-systolic volume End-diastolic volume Left atrial volume
Time frame: baseline, 30 days and 12 months
left ventricular ejection fraction modification
Left ventricular ejection fraction
Time frame: baseline, 30 days and 12 months
mitral valve remodelling
Mitral valve area and mean gradient
Time frame: baseline, 30 days and 12 months
Left atrial and pulmonary artery pressures
Left atrial and pulmonary artery pressures
Time frame: baseline, 30 days and 12 months
change in 6-minute Walking Test (functional evaluation)
6-minute Walking Test
Time frame: baseline, 6 and 12 months
surveillance of cardiac and renal function
NT ProBNP or BNP creatininemia, ureamia
Time frame: baseline, 30 days, 6, 12 and 24 months
change in Quality of Life scores
Quality of Life EQ-5D score SF-36 score
Time frame: baseline, 30 days, 6, 12 and 24 months
Cost-effectiveness analysis (economic efficiency)
Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY)
Time frame: 24 months
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital