Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation

Inclusion criteria

• Age > 18 years old
• Severe secondary mitral regurgitation characterised, according to the European guidelines and recommendations, by a regurgitant volume>30 mL/beat or an effective regurgitant orifice>20 mm².
• New York heart Association Class≥ II.
• Left ventricular ejection fraction between 15% and 40%
• Minimum of 1 hospitalization for heart failure within 12 months preceding randomization
• Optimal standard of care therapy for heart failure according to investigator.
• Not eligible for a mitral surgery intervention according to the Heart Team.
• Willingness to participate in the study and signed written informed consent
• Affiliation to a health insurance system or a similar system

Exclusion criteria

• Eligible for a mitral surgery intervention according to the Heart Team.
• Primary mitral regurgitation.
• Myocardial infarction or coronary bypass grafting surgery within three months prior to randomization.
• Cardiac resynchronization therapy within three months prior to randomization.
• Cardioversion within three months prior to randomization
• Transcatheter aortic valve implantation within three months prior to randomization
• Need for any cardiovascular surgery (including registration on cardiac transplant list).
• Coronary angioplasty within one month prior to randomization.
• Previous surgical mitral valve repair.
• Renal replacement therapy.
• Active infection requiring current antibiotic therapy.
• Severe hepatic insufficiency.
• Stroke within three months prior to randomization.
• Concurrent medical condition with a life expectancy of less than 12 months.
• Uncontrolled arterial hypertension.
• Hypersensitivity to nitinol.
• Participation to another trial.
• Pregnancy.
• No affiliation to a health insurance system.
• Legal protection measure (guardianship or curatorship)