Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation
NCT ID: NCT01920698
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
304 participants
INTERVENTIONAL
2013-11-30
2019-03-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Multicentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
NCT03271762
A Clinical Evaluation of the Safety and Effectiveness of the MitraClip System in the Treatment of Clinically Significant Functional Mitral Regurgitation
NCT02444338
MitraClip for the Treatment of Moderate Functional Mitral Regurgitation: EVOLVE-MR
NCT03705312
A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation
NCT01772108
Transcatheter Mitral Valve Repair for the Treatment of Mitral Valve Regurgitation In Heart Failure (The EVOLVE-MR Trial)
NCT03891823
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MitraClip Device
Subjects randomized to the MitraClip Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy.
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
control
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Percutaneous MitraClip Device Implantation
MitraClip System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system
control
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
JEAN FRANCOIS OBADIA, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU d'Angers
Angers, , 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, , France
Hôpital Gabriel Montpied
Clermont-Ferrand, , France
APHP Hôpital Henri Mondor
Créteil, , France
CHU de Grenoble
Grenoble, , France
Hôpital privé de Parly 2
Le Chesnay, , France
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, , France
Chu de Lille
Lille, , France
Hôpital privé le Bois
Lille, , France
Hôpital Saint-Joseph
Marseille, , France
Hopital de La Timone
Marseille, , France
Hôpital privé Clairval
Marseille, , France
Institut Hospitalier Jacques Cartier
Massy, , France
CH Annecy Genevois
Metz-Tessy, , 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, , France
Hôpital Pasteur
Nice, , France
Groupe Hospitalier La Salpétrière
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , 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, , France
Institut Arnault Tzanck
Saint-Laurent-du-Var, , France
Chu de Strasbourg
Strasbourg, , France
Clinique Pasteur
Toulouse, , France
Chu de Toulouse
Toulouse, , France
CHRU de Tours
Tours, , France
Clinique Cardiologique Saint Gatien
Tours, , France
Clinique du Tonkin
Villeurbanne, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-A00464-41
Identifier Type: OTHER
Identifier Source: secondary_id
2013.798
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.