Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR)
|ClinicalTrials.gov Identifier: NCT01920698|
Recruitment Status : Unknown
Verified July 2018 by Hospices Civils de Lyon.
Recruitment status was: Active, not recruiting
First Posted : August 12, 2013
Last Update Posted : July 10, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Device: Percutaneous MitraClip Device Implantation Other: control||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentre Randomized Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation.|
|Actual Study Start Date :||November 2013|
|Actual Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2019|
Experimental: MitraClip Device
Subjects randomized to the MitraClip Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy.
Device: Percutaneous MitraClip Device Implantation
MitraClip System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system
Patients randomized to the Control group will receive optimal therapy alone
Other Name: Patients randomized to the Control Group will receive optimal medical therapy alone
- 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 [ Time Frame: 30 days, 6 months, 12 months and 24 months. ]Any serious adverse events cardiovascular or not occurring within each group.
- 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920698
|Principal Investigator:||JEAN FRANCOIS OBADIA, MD||Hospices Civils de Lyon|