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

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Mitral Regurgitation

Treatments: Device: percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW; Procedure: cardiac surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03271762

RC17_0002

Details and patient eligibility

About

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).

Enrollment: 330 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 2 patient groups

MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW Device

Experimental group

Description:

MitraClip NT System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system

Treatment:

Device: percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW

cardiac surgery

Active Comparator group

Description:

mitral valve repair in first intervention, valve replacement if repair not feasible

Treatment:

Procedure: cardiac surgery