Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation
MITRA-FR
Multicentre Randomized Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation.
2 other identifiers
interventional
304
1 country
40
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cardiovascular-diseases
Started Nov 2013
Longer than P75 for not_applicable cardiovascular-diseases
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2013
CompletedFirst Posted
Study publicly available on registry
August 12, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2019
CompletedSeptember 4, 2025
August 1, 2025
4.4 years
August 8, 2013
August 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality and unplanned hospitalizations for heart failure
1 year
Secondary Outcomes (8)
All-cause mortality, cardiac mortality
30 days, 6 months, 12 months, and 24 months.
Survival with no major cardiovascular events
30 days, 6 months, 12 months, and 24 months.
Serious Adverse Events
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.
6 months and 12 months
Change in functional evaluation
12 months
- +3 more secondary outcomes
Study Arms (2)
MitraClip Device
EXPERIMENTALSubjects randomized to the MitraClip Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy.
Control
OTHERPatients randomized to the Control group will receive optimal therapy alone
Interventions
MitraClip System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
CHU d'Angers
Angers, 49933, France
Chu de Besancon
Besançon, France
Chu de Bordeaux
Bordeaux, France
CHRU La Cavale Blanche
Brest, France
Groupement Hospitalier Est
Bron, France
CHU Caen
Caen, 14000, France
Hôpital Gabriel Montpied
Clermont-Ferrand, 63000, France
APHP Hôpital Henri Mondor
Créteil, France
CHU de Grenoble
Grenoble, 38700, France
Hôpital privé de Parly 2
Le Chesnay, 78150, France
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, France
Chu de Lille
Lille, France
Hôpital privé le Bois
Lille, France
Hôpital Saint-Joseph
Marseille, 13285, France
Hopital de La Timone
Marseille, France
Hôpital privé Clairval
Marseille, France
Institut Hospitalier Jacques Cartier
Massy, France
CH Annecy Genevois
Metz-Tessy, 74370, France
Chu de Montpellier
Montpellier, France
Clinique Du Millenaire
Montpellier, France
Chu de Nancy
Nancy, France
Chu de Nantes
Nantes, France
Centre chirurgicale Ambroise Paré
Neuilly-sur-Seine, 92200, France
Hôpital Pasteur
Nice, 06001, France
Groupe Hospitalier La Salpétrière
Paris, 75013, France
Institut Mutualiste Montsouris
Paris, 75014, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Aphp Hopital Bichat
Paris, France
CHRU La Milétrie
Poitiers, France
Chu de Rennes
Rennes, France
CHU Rouen
Rouen, France
Centre Cardiologique du Nord
Saint-Denis, France
Hôpital Nord
Saint-Etienne, 42055, France
Institut Arnault Tzanck
Saint-Laurent-du-Var, France
Chu de Strasbourg
Strasbourg, France
Clinique Pasteur
Toulouse, 31076, France
Chu de Toulouse
Toulouse, France
CHRU de Tours
Tours, France
Clinique Cardiologique Saint Gatien
Tours, France
Clinique du Tonkin
Villeurbanne, France
Related Publications (5)
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.
PMID: 25798568BACKGROUNDIung 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.
PMID: 31476260BACKGROUNDObadia 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.
PMID: 30145927RESULTIung 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.
PMID: 33347327DERIVEDMessika-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.
PMID: 32950444DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
JEAN FRANCOIS OBADIA, MD
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2013
First Posted
August 12, 2013
Study Start
November 1, 2013
Primary Completion
April 1, 2018
Study Completion
March 5, 2019
Last Updated
September 4, 2025
Record last verified: 2025-08