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Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR)

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ClinicalTrials.gov Identifier: NCT01920698
Recruitment Status : Unknown
Verified September 2015 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : August 12, 2013
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):

August 8, 2013
August 12, 2013
September 22, 2015
November 2013
October 2016   (Final data collection date for primary outcome measure)
All-cause mortality and unplanned hospitalizations for heart failure [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01920698 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 and 6 and 12 months. [ Time Frame: 6 months and 12 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.
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cardiovascular Diseases
  • Device: Percutaneous MitraClip Device Implantation
    MitraClip System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system
  • Other: control
    Other Name: Patients randomized to the Control Group will receive optimal medical therapy alone
  • Experimental: MitraClip Device
    Subjects randomized to the MitraClip Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy.
    Intervention: Device: Percutaneous MitraClip Device Implantation
  • Control
    Patients randomized to the Control group will receive optimal therapy alone
    Intervention: Other: control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
288
October 2017
October 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years old
  • Severe secondary mitral regurgitation confirmed by the Echocardiography Core Laboratory
  • Characterized by a regurgitation volume > 30 mL/beat or a regurgitant orifice area > 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
  • Assessed by the investigator to be on optimal standard of care therapy for heart failure
  • Assessed by the heart team to be not eligible to a mitral surgery intervention

Exclusion Criteria:

  • Primary mitral regurgitation
  • Myocardial infarction or coronary bypass grafting surgery within 3 months prior to randomization
  • Cardiac resynchronization therapy within 3 months prior to randomization
  • Cardioversion within 3 months prior to randomization
  • Need for any cardiovascular surgery (including registration on cardiac transplant list)
  • Coronary angioplasty within 1 month prior to randomization
  • History of mitral valve repair
  • Active infection requiring current antibiotic therapy
  • Terminal renal insufficiency (renal replacement therapy)
  • Severe hepatic insufficiency
  • Evidence of stroke within 3 months prior to randomization
  • Concurrent medical condition with a life expectancy of less than 12 months
  • Uncontrolled hypertension
  • Known hypersensitivity to nitinol
  • Currently participating in another trial
  • Pregnant women
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01920698
2013.798
Yes
Not Provided
Not Provided
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Principal Investigator: JEAN FRANCOIS OBADIA, MD Hospices Civils de Lyon
Hospices Civils de Lyon
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP