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
Among 42 studies in Mitral Valve Insufficiency with a site in France — 17 open to participants now, 21 under way, none of them phase 3. Mitral Valve Insufficiency · France.
Among the 42 studies in Mitral Valve Insufficiency with a site in France, this one is the 4th largest by planned enrollment of the 26 interventional ones, is one of 3 that started in 2018, is one of 25 with no phase, reaches primary completion later than 8 of the 20 other live ones, and was the 20th registered.
468 studies on the registry are indexed under Mitral Valve Insufficiency; 164 are open to participants now.
This study's planned enrollment of 330 is above the median of 68 across 279 interventional studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →17 of the 42 studies in Mitral Valve Insufficiency with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 122 Mitral Valve Insufficiency studies recruiting now, 101 (83%) set no upper age limit and 6 (5%) stop at 75 or younger; 13 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →42 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 3 started in 2018.
Median enrollment 57 across the 26 interventional studies, 470 across the 16 observational. Of the 12 that completed or were terminated, 5 (42%) have results posted.
23 of 42 have an industry lead sponsor. The 10 most frequent:
Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Nantes University Hospital has 1 study filed under Mitral Valve Insufficiency — fewer than ten, so there is no comparison to draw.
6 of the studies in Mitral Valve Insufficiency with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06648577Assistance Publique - Hôpitaux de Paris3D Ultrasound Myocardial Mechanical Wave Measurements | 2026-11-15 |
| NCT03271762Nantes University HospitalMulticentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery | 2026-12 |
| NCT02925819French Cardiology SocietyManagement and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery | 2026-12 |
| NCT04029363HighLife SASExpanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk | 2026-12-15 |
| NCT03142152Cardiac Dimensions, Inc.The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR | 2026-12-31 |
Among the 42 studies in Mitral Valve Insufficiency with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Primary Mitral Regurgitation grade 3+ or 4+
Non-inclusion Criteria:
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Started Mar 2018 (actual). Primary completion is estimated for Dec 2026, 105 months after the start.
Of 143 interventional studies with no phase under Mitral Valve Insufficiency, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 108. This study's planned 105 months is above that.
How these figures are worked out, and which studies are left out of them.
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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