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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 July 2018 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : August 12, 2013
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Device: Percutaneous MitraClip Device Implantation Other: control Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Control
Patients randomized to the Control group will receive optimal therapy alone
Other: control
Other Name: Patients randomized to the Control Group will receive optimal medical therapy alone




Primary Outcome Measures :
  1. All-cause mortality and unplanned hospitalizations for heart failure [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. All-cause mortality, cardiac mortality [ Time Frame: 30 days, 6 months, 12 months, and 24 months. ]
  2. Survival with no major cardiovascular events [ Time Frame: 30 days, 6 months, 12 months, and 24 months. ]
  3. 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.

  4. Change in Quality of Life score as measured by the European Quality of Life-5 Dimensions instrument. [ Time Frame: 6 months and 12 months ]
  5. Change in functional evaluation [ Time Frame: 12 months ]
  6. Change in echocardiographic evaluation between baseline at 6, 12 and 24 months. [ Time Frame: 6 months, 12 months and 24 months ]
  7. Change in biomarkers (BNP levels, creatinine) at 6 months and 12 months [ Time Frame: 6 months and 12 months ]
  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920698


Locations
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Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: JEAN FRANCOIS OBADIA, MD Hospices Civils de Lyon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01920698    
Other Study ID Numbers: 2013.798
2013-A00464-41 ( Other Identifier: IDRCB )
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Keywords provided by Hospices Civils de Lyon:
Heart Valve Diseases
Heart failure
Heart diseases
Mitral valve insufficiency
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Cardiovascular Diseases
Heart Valve Diseases
Heart Diseases