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

Phase 3

• Conditions: Cardiovascular Diseases

• Registration Number: NCT01920698
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-09
• Study First Posted: 2013-08-12
• Study Start: 2013-11
• Primary Completion: 2018-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-09
• Last Update Posted: 2018-07-10
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 288

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
All-cause mortality and unplanned hospitalizations for heart failure	1 year

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life score as measured by the European Quality of Life-5 Dimensions instrument.	6 months and 12 months
Change in echocardiographic evaluation between baseline at 6, 12 and 24 months.	6 months, 12 months and 24 months
Change in functional evaluation	12 months
Cost-effectiveness of each strategy at 12 months	12 months	Cost-effectiveness of each therapeutic strategy will be assessed by the evaluation of medical costs linked to the pathology (hospitalizations, consultations, and external medical costs (biology, radiology, medications) and compared in the 2 groups during the first 12 months of follow up.
Serious Adverse Events	30 days, 6 months, 12 months and 24 months.	Any serious adverse events cardiovascular or not occurring within each group.
All-cause mortality, cardiac mortality	30 days, 6 months, 12 months, and 24 months.
Survival with no major cardiovascular events	30 days, 6 months, 12 months, and 24 months.
Change in biomarkers (BNP levels, creatinine) at 6 months and 12 months	6 months and 12 months

Trial Locations

Locations (40)

CHU d'Angers; 🇫🇷 Angers, France

Chu de Besancon; 🇫🇷 Besancon, France

Chu de Bordeaux; 🇫🇷 Bordeaux, France

CHRU La Cavale Blanche; 🇫🇷 Brest, France

Groupement Hospitalier Est; 🇫🇷 Bron, France

CHU Caen; 🇫🇷 Caen, France

Hôpital Gabriel Montpied; 🇫🇷 Clermont Ferrand, France

APHP Hôpital Henri Mondor; 🇫🇷 Creteil, France

CHU de Grenoble; 🇫🇷 Grenoble, France

Hôpital privé de Parly 2; 🇫🇷 Le Chesnay, France

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