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

Hospices Civils de Lyon40 sites in 1 country304 target enrollmentNovember 1, 2013

ConditionsCardiovascular Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiovascular Diseases
Sponsor: Hospices Civils de Lyon
Enrollment: 304
Locations: 40
Primary Endpoint: All-cause mortality and unplanned hospitalizations for heart failure
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 1, 2013

End Date

March 5, 2019

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

All-cause mortality and unplanned hospitalizations for heart failure

Time Frame: 1 year

Secondary Outcomes

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)
Serious Adverse Events(30 days, 6 months, 12 months and 24 months.)
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)