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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
304
MitraClip System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system
All-cause mortality and unplanned hospitalizations for heart failure
Time frame: 1 year
All-cause mortality, cardiac mortality
Time frame: 30 days, 6 months, 12 months, and 24 months.
Survival with no major cardiovascular events
Time frame: 30 days, 6 months, 12 months, and 24 months.
Serious Adverse Events
Any serious adverse events cardiovascular or not occurring within each group.
Time frame: 30 days, 6 months, 12 months and 24 months.
Change in Quality of Life score as measured by the European Quality of Life-5 Dimensions instrument.
Time frame: 6 months and 12 months
Change in functional evaluation
Time frame: 12 months
Change in echocardiographic evaluation between baseline at 6, 12 and 24 months.
Time frame: 6 months, 12 months and 24 months
Change in biomarkers (BNP levels, creatinine) at 6 months and 12 months
Time frame: 6 months and 12 months
Cost-effectiveness of each strategy at 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.
Time frame: 12 months
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