Status:
ACTIVE_NOT_RECRUITING
Multicentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Ministère de la Santé
Abbott
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
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 pat...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT03271762
Start Date
March 2 2018
End Date
January 1 2028
Last Update
November 26 2025
Active Locations (31)
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1
Chu Angers
Angers, France
2
Ch Annecy
Annecy, France, 74370
3
Chu Bordeaux
Bordeaux, France
4
Chru Brest
Brest, France