Multicentre Study of MITRACLIP Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery

  • STATUS
    Recruiting
  • End date
    May 30, 2025
  • participants needed
    330
  • sponsor
    Nantes University Hospital
Updated on 30 May 2021
endocarditis
coronary artery disease
stroke
medical therapy
regurgitation
heart surgery
mitral valve disease
rheumatic
mitral valve repair
transesophageal echocardiography
cardiovascular surgery
carotid surgery
tricuspid regurgitation

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).

Details
Condition VALVULAR HEART DISEASE, Mitral Regurgitation, Heart Valve Disease, Mitral Valve Regurgitation, mitral insufficiency, mitral valve insufficiency
Treatment Cardiac surgery, percutaneous mitral valve repair with MITRACLIP NT, percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW
Clinical Study IdentifierNCT03271762
SponsorNantes University Hospital
Last Modified on30 May 2021

Eligibility

Yes No Not Sure

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
If revascularization procedures are required, they must be performed more than 30 days from intervention (D0)
Isolated Mitral valve pathology
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
Valve anatomy not compatible with MitraClip implantation (cf. colum 3 table 3 page 57)
Stroke or transient ischaemic event within 30 days before D0
Patient who cannot tolerate procedural anticoagulation or post procedural antiplatelet regimen
Rheumatic mitral valve disease
TAVR within 30 days before D0-Untreated, clinically significant coronary artery disease requiring revascularization
Evidence of intracardiac, inferior vena cava or femoral venous thrombus
Any percutaneous cardiovascular intervention within 30 days before D0 including ATC
Cardiovascular surgery, or carotid surgery within 30 days before D0
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
Modified Rankin Scale 4 disability (appendix 9)
Any prior mitral valve surgery or transcatheter mitral valve procedure
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

Before randomization (D-21) the patient no longer fulfills eligibility criteria (inclusion criteria and non-inclusion criteria)
Not eligible for a MitraClip intervention after Core Lab evaluation
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