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

July 9, 2018 updated by: Hospices Civils de Lyon

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

288

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • CHU d'Angers
      • Besancon, France
        • CHU de Besancon
      • Bordeaux, France
        • CHU de Bordeaux
      • Brest, France
        • CHRU La Cavale Blanche
      • Bron, France
        • Groupement Hospitalier Est
      • Caen, France, 14000
        • CHU caen
      • Clermont Ferrand, France, 63000
        • Hôpital Gabriel Montpied
      • Creteil, France
        • APHP Hôpital Henri Mondor
      • Grenoble, France, 38700
        • CHU de Grenoble
      • Le Chesnay, France, 78150
        • Hôpital privé de Parly 2
      • Le Plessis Robinson, France
        • Centre Chirurgical Marie Lannelongue
      • Lille, France
        • CHU de Lille
      • Lille, France
        • Hôpital Privé Le Bois
      • Marseille, France
        • Hopital de la Timone
      • Marseille, France
        • Hôpital privé Clairval
      • Marseille, France, 13285
        • Hôpital Saint-Joseph
      • Massy, France
        • Institut Hospitalier Jacques Cartier
      • Metz-Tessy, France, 74370
        • Ch Annecy Genevois
      • Montpellier, France
        • CHU de Montpellier
      • Montpellier, France
        • Clinique du Millénaire
      • Nancy, France
        • Chu de Nancy
      • Nantes, France
        • CHU de Nantes
      • Neuilly Sur Seine, France, 92200
        • Centre chirurgicale Ambroise Paré
      • Nice, France, 06001
        • Hôpital Pasteur
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
      • Paris, France
        • APHP Hôpital Bichat
      • Paris, France, 75013
        • Groupe Hospitalier La Salpétrière
      • Poitiers, France
        • CHRU La Milétrie
      • Rennes, France
        • CHU de Rennes
      • Rouen, France
        • CHU Rouen
      • Saint Denis, France
        • Centre Cardiologique du Nord
      • Saint Laurent Du Var, France
        • Institut Arnault Tzanck
      • Saint-Étienne, France, 42055
        • Hopital Nord
      • Strasbourg, France
        • CHU de Strasbourg
      • Toulouse, France, 31076
        • Clinique PASTEUR
      • Toulouse, France
        • CHU de Toulouse
      • Tours, France
        • CHRU De Tours
      • Tours, France
        • Clinique Cardiologique Saint Gatien
      • Villeurbanne, France
        • Clinique du Tonkin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other: Control
Patients randomized to the Control group will receive optimal therapy alone
Other: control
Other Names:
  • Patients randomized to the Control Group will receive optimal medical therapy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality and unplanned hospitalizations for heart failure
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality, cardiac mortality
Time Frame: 30 days, 6 months, 12 months, and 24 months.
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.
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.
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
6 months and 12 months
Change in functional evaluation
Time Frame: 12 months
12 months
Change in echocardiographic evaluation between baseline at 6, 12 and 24 months.
Time Frame: 6 months, 12 months and 24 months
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
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: JEAN FRANCOIS OBADIA, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

April 1, 2018

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 9, 2013

First Posted (Estimate)

August 12, 2013

Study Record Updates

Last Update Posted (Actual)

July 10, 2018

Last Update Submitted That Met QC Criteria

July 9, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013.798
  • 2013-A00464-41 (Other Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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