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

August 27, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
304

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
      • Besançon, France
        • CHU de Besançon
      • 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
        • Hopital Gabriel Montpied
      • Créteil, 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
        • Hopital Prive le Bois
      • Marseille, France
        • Hopital de la Timone
      • Marseille, France
        • Hopital Prive 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-Etienne, France, 42055
        • Hopital Nord
      • Saint-Laurent-du-Var, France
        • Institut Arnault Tzanck
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
All-cause mortality and unplanned hospitalizations for heart failure
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2013

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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