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

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

The objective of this trial is to compare the safety, the efficacy and the cost-effectiveness of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous MitraClip procedure and optimal standard of care therapy) in patients with severe secondary mitral regurgitation.

This trial is a French, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12 months and 24 months).

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)