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Cardiovascular DiseasesMITRA-FRNCT01920698

Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation

A study testing Percutaneous MitraClip Device Implantation in people with Cardiovascular Diseases, run by Hospices Civils de Lyon at 40 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Percutaneous MitraClip Device Implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
304 participants
Where
40 sitesFrance
Study dates
Nov 2013to 5 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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)

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

France40 sites

  • CHU d'Angers

    Angers, 49933

  • Chu de Besancon

    Besançon

  • Chu de Bordeaux

    Bordeaux

  • CHRU La Cavale Blanche

    Brest

  • Groupement Hospitalier Est

    Bron

  • CHU Caen

    Caen, 14000

  • Hôpital Gabriel Montpied

    Clermont-Ferrand, 63000

  • APHP Hôpital Henri Mondor

    Créteil

  • CHU de Grenoble

    Grenoble, 38700

  • Hôpital privé de Parly 2

    Le Chesnay, 78150

  • Centre Chirurgical Marie Lannelongue

    Le Plessis-Robinson

  • Chu de Lille

    Lille

  • Hôpital privé le Bois

    Lille

  • Hôpital Saint-Joseph

    Marseille, 13285

  • Hopital de La Timone

    Marseille

  • Hôpital privé Clairval

    Marseille

  • Institut Hospitalier Jacques Cartier

    Massy

  • CH Annecy Genevois

    Metz-Tessy, 74370

  • Chu de Montpellier

    Montpellier

  • Clinique Du Millenaire

    Montpellier

  • Chu de Nancy

    Nancy

  • Chu de Nantes

    Nantes

  • Centre chirurgicale Ambroise Paré

    Neuilly-sur-Seine, 92200

  • Hôpital Pasteur

    Nice, 06001

  • Groupe Hospitalier La Salpétrière

    Paris, 75013

  • Institut Mutualiste Montsouris

    Paris, 75014

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • Aphp Hopital Bichat

    Paris

  • CHRU La Milétrie

    Poitiers

  • Chu de Rennes

    Rennes

  • CHU Rouen

    Rouen

  • Centre Cardiologique du Nord

    Saint-Denis

  • Hôpital Nord

    Saint-Etienne, 42055

  • Institut Arnault Tzanck

    Saint-Laurent-du-Var

  • Chu de Strasbourg

    Strasbourg

  • Clinique Pasteur

    Toulouse, 31076

  • Chu de Toulouse

    Toulouse

  • CHRU de Tours

    Tours

  • Clinique Cardiologique Saint Gatien

    Tours

  • Clinique du Tonkin

    Villeurbanne

Other trials in France

About this study

Official title: 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).

Being tested
Percutaneous MitraClip Device Implantation, control
Keywords
Heart Valve Diseases, Heart failure, Heart diseases, Mitral valve insufficiency
Medical subject headings
Cardiovascular Diseases, Heart Valve Diseases, Heart Failure, Heart Diseases, Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous MitraClip Device ImplantationDevice

    MitraClip System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system

  • controlOther

    Also called Patients randomized to the Control Group will receive optimal medical therapy alone

Study groups in NCT01920698
Study groupRoleWhat they receive
MitraClip DeviceExperimentalSubjects randomized to the MitraClip Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy.
Receives: Device: Percutaneous MitraClip Device Implantation
ControlOtherPatients randomized to the Control group will receive optimal therapy alone
Receives: Other: control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality and unplanned hospitalizations for heart failure

    Measured: 1 year

Secondary outcomes (8)

  1. All-cause mortality, cardiac mortality

    Measured: 30 days, 6 months, 12 months, and 24 months.

  2. Survival with no major cardiovascular events

    Measured: 30 days, 6 months, 12 months, and 24 months.

  3. Serious Adverse Events

    Any serious adverse events cardiovascular or not occurring within each group.

    Measured: 30 days, 6 months, 12 months and 24 months.

  4. Change in Quality of Life score as measured by the European Quality of Life-5 Dimensions instrument.

    Measured: 6 months and 12 months

  5. Change in functional evaluation

    Measured: 12 months

  6. Change in echocardiographic evaluation between baseline at 6, 12 and 24 months.

    Measured: 6 months, 12 months and 24 months

  7. Change in biomarkers (BNP levels, creatinine) at 6 months and 12 months

    Measured: 6 months and 12 months

  8. Cost-effectiveness of each strategy at 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionApr 2018
  4. Study completion5 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01920698
Sponsor's protocol ID
2013.798
Other IDs
2013-A00464-41
Acronym
MITRA-FR
Status last verified
Aug 2025
First submitted
8 Aug 2013
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Obadia JF, Armoiry X, Iung B, Lefevre T, Mewton N, Messika-Zeitoun D, Cormier B, Berthiller J, Maucort-Boulch D, Boutitie F, Vaz B, Trochu JN, Vahanian A. The MITRA-FR study: design and rationale of a randomised study of percutaneous mitral valve repair compared with optimal medical management alone for severe secondary mitral regurgitation. EuroIntervention. 2015 Mar;10(11):1354-60. doi: 10.4244/EIJV10I11A232.

    PubMed 25798568

  • Iung B, Armoiry X, Vahanian A, Boutitie F, Mewton N, Trochu JN, Lefevre T, Messika-Zeitoun D, Guerin P, Cormier B, Brochet E, Thibault H, Himbert D, Thivolet S, Leurent G, Bonnet G, Donal E, Piriou N, Piot C, Habib G, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Saint Etienne C, Leroux L, Gilard M, Samson G, Rioufol G, Maucort-Boulch D, Obadia JF; MITRA-FR Investigators. Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years. Eur J Heart Fail. 2019 Dec;21(12):1619-1627. doi: 10.1002/ejhf.1616. Epub 2019 Nov 18.

    PubMed 31476260

  • Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27.

    PubMed 30145927

  • Iung B, Messika-Zeitoun D, Boutitie F, Trochu JN, Armoiry X, Maucort-Boulch D, Obadia JF, Vahanian A. Characteristics and Outcome of COAPT-Eligible Patients in the MITRA-FR Trial. Circulation. 2020 Dec 22;142(25):2482-2484. doi: 10.1161/CIRCULATIONAHA.120.049743. Epub 2020 Dec 21. No abstract available.

    PubMed 33347327

  • Messika-Zeitoun D, Iung B, Armoiry X, Trochu JN, Donal E, Habib G, Brochet E, Thibault H, Piriou N, Cormier B, Tribouilloy C, Guerin P, Lefevre T, Maucort-Boulch D, Vahanian A, Boutitie F, Obadia JF. Impact of Mitral Regurgitation Severity and Left Ventricular Remodeling on Outcome After MitraClip Implantation: Results From the Mitra-FR Trial. JACC Cardiovasc Imaging. 2021 Apr;14(4):742-752. doi: 10.1016/j.jcmg.2020.07.021. Epub 2020 Sep 16.

    PubMed 32950444

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous MitraClip Device Implantation in people with Cardiovascular Diseases, run by Hospices Civils de Lyon at 40 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality and unplanned hospitalizations for heart failure (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01920698, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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