Mitral Regurgitation
Conditions
Keywords
MITRACLIP, primary Mitral Regurgitation, high surgical risks
Brief summary
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).
Interventions
DEVICEpercutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW
percutaneous mitral valve repair Percutaneous MitraClip Device Implantation
PROCEDUREcardiac surgery
mitral valve repair or mitral valve remplacement
Sponsors
Ministère de la Santé
Abbott
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary Mitral Regurgitation grade 3+ or 4+ * Patients in class II to IV NYHA * Mitral valve anatomy appropriate to MitraClip® therapy and mitral valve surgery * Adult patients judged eligible for mitral valve surgery by the local heart team but at high surgical risk defined as: age ≥ 75 years and STS score ≥ 6 % or one frailty index or one major organ system compromise or one possible procedure-specific impediment (using MVARC definitions) ; or age \< 75 years and STS score \> 8 % or at least one other high-risk criterion following the MVARC definitions; or age \> 80 years and judged at high risk for surgery by the local heart team * Isolated Mitral valve pathology * If revascularization procedures are required, they must be performed more than 30 days from intervention (D0) * Patients affiliate to social security Non-inclusion Criteria: * Life expectancy \< 1 year due to non-cardiac conditions * Secondary Mitral regurgitation * Evolving endocarditis or active endocarditis or inflammatory disease in the last 3 months * Patient who cannot tolerate procedural anticoagulation or post procedural antiplatelet regimen * Rheumatic mitral valve disease * Evidence of intracardiac, inferior vena cava or femoral venous thrombus * Valve anatomy not compatible with MitraClip® implantation (cf. colum 3 table 3 page 57) * Stroke or transient ischaemic event within 30 days before D0 * Modified Rankin Scale ≥4 disability (appendix 9) * TAVR within 30 days before D0-Untreated, clinically significant coronary artery disease requiring revascularization * Any percutaneous cardiovascular intervention within 30 days before D0 including ATC * Cardiovascular surgery, or carotid surgery within 30 days before D0 * Any prior mitral valve surgery or transcatheter mitral valve procedure * Need for any concomitant cardiac surgery including treatment of severe secondary tricuspid regurgitation in accordance with class I recommendation in 2017 ESC guidelines. Surgical treatment of mild or moderate secondary tricuspid regurgitation (Class IIa and IIb recommendations) can still be performed in the protocol according to the local heart team decison * NYHA functional class I * LVEF \< 30% * Primary MR grade 1 to 2 * Subjects in whom transesophageal echocardiography or transseptal catheterization are contraindicated or high-risk * Any condition preventing the patient from completing all protocol procedures (including compliance with guidelines directed medical therapy) and follow-up visits * Patient unable or unwilling to provide written, informed consent before study enrolment * Pregnant or nursing women * Vulnerable people: persons deprived of liberty; under trusteeship or under curatorship * Participation in another trial that would interfere with this trial
Exclusion criteria
* Not eligible for a MitraClip® intervention after Core Lab evaluation * Before randomization (D-21) the patient no longer fulfills eligibility criteria (inclusion criteria and non-inclusion criteria)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality, unplanned hospitalizations for heart failure and mitral valve reintervention | 12 months | comparison between arms of: * number and reason of death * number and reason unplanned rehospitalisation for cardiovascular reasons, * number of mitral valve reintervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of a major adverse event | 30 days | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall rate of surgery related Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) Effects (SADEs) | 6, 12 and 24 months | SAEs et SADEs rate related to protocol procedure all SAEs and SADEs |
| all-cause mortality | 30 days and 6, 12 and 24 months | Rate of global mortality (all-causes) |
| cardiovascular mortality | 30 days and 6, 12 and 24 months | Rate of cardiovascular mortality |
| unplanned heart failure rehospitalization | 6, 12 and 24 months | Rate of unplanned heart failure rehospitalization |
| unplanned rehospitalization rate for cardiovascular reasons | 30 days 6, 12 and 24 months | Rate of unplanned rehospitalization for cardiovascular reasons |
| mitral valve reintervention | 30 days 6, 12 and 24 months | Mitral valve reintervention rate |
| residual MR | 30 days 6, 12 and 24 months | MR (Mitral Regurgitation): grade |
| change in Quality of Life scores | baseline, 30 days, 6, 12 and 24 months | Quality of Life EQ-5D score SF-36 score |
| left and right chamber remodelling and parameters (volume) | baseline, 30 days and 12 months | End-systolic volume End-diastolic volume Left atrial volume |
| left ventricular ejection fraction modification | baseline, 30 days and 12 months | Left ventricular ejection fraction |
| mitral valve remodelling | baseline, 30 days and 12 months | Mitral valve area and mean gradient |
| Left atrial and pulmonary artery pressures | baseline, 30 days and 12 months | Left atrial and pulmonary artery pressures |
| change in 6-minute Walking Test (functional evaluation) | baseline, 6 and 12 months | 6-minute Walking Test |
| surveillance of cardiac and renal function | baseline, 30 days, 6, 12 and 24 months | NT ProBNP or BNP creatininemia, ureamia |
| left and right chamber remodelling and parameters (dimension) | baseline, 30 days and 12 months | End-systolic dimension End-diastolic dimension Left atrial dimension |
| Cost-effectiveness analysis (economic efficiency) | 24 months | Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY) |
Countries
France
Outcome results
None listed