Clinical trial NCT01920698: Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation
Official title: Multicentre Randomized Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cardiovascular Diseases
Keywords: Heart Valve Diseases
Heart failure
Heart diseases
Mitral valve insufficiency
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-08-12
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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)

Primary outcomes:
measure: All-cause mortality and unplanned hospitalizations for heart failure
timeFrame: 1 year
Secondary outcomes:
measure: All-cause mortality, cardiac mortality
timeFrame: 30 days, 6 months, 12 months, and 24 months.
measure: Survival with no major cardiovascular events
timeFrame: 30 days, 6 months, 12 months, and 24 months.
measure: Serious Adverse Events
timeFrame: 30 days, 6 months, 12 months and 24 months.
measure: Change in Quality of Life score as measured by the European Quality of Life-5 Dimensions instrument.
timeFrame: 6 months and 12 months
measure: Change in functional evaluation
timeFrame: 12 months
measure: Change in echocardiographic evaluation between baseline at 6, 12 and 24 months.
timeFrame: 6 months, 12 months and 24 months
measure: Change in biomarkers (BNP levels, creatinine) at 6 months and 12 months
timeFrame: 6 months and 12 months
measure: Cost-effectiveness of each strategy at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Besancon
country: France
facility: Chu de Besancon
city: Bordeaux
country: France
facility: Chu de Bordeaux
city: Brest
country: France
facility: CHRU La Cavale Blanche
city: Bron
country: France
facility: Groupement Hospitalier Est
city: Caen
country: France
facility: CHU Caen
city: Clermont Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Creteil
country: France
facility: APHP Hôpital Henri Mondor
city: Grenoble
country: France
facility: CHU de Grenoble
city: Le Chesnay
country: France
facility: Hôpital privé de Parly 2
city: Le Plessis Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
city: Lille
country: France
facility: Chu de Lille
city: Lille
country: France
facility: Hôpital privé le Bois
city: Marseille
country: France
facility: Hôpital Saint-Joseph
city: Marseille
country: France
facility: Hopital de La Timone
city: Marseille
country: France
facility: Hôpital privé Clairval
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Metz-Tessy
country: France
facility: CH Annecy Genevois
city: Montpellier
country: France
facility: Chu de Montpellier
city: Montpellier
country: France
facility: Clinique Du Millenaire
city: Nancy
country: France
facility: Chu de Nancy
city: Nantes
country: France
facility: Chu de Nantes
city: Neuilly Sur Seine
country: France
facility: Centre chirurgicale Ambroise Paré
city: Nice
country: France
facility: Hôpital Pasteur
city: Paris
country: France
facility: Groupe Hospitalier La Salpétrière
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Aphp Hopital Bichat
city: Poitiers
country: France
facility: CHRU La Milétrie
city: Rennes
country: France
facility: Chu de Rennes
city: Rouen
country: France
facility: CHU Rouen
city: Saint Denis
country: France
facility: Centre Cardiologique du Nord
city: Saint Laurent Du Var
country: France
facility: Institut Arnault Tzanck
city: Saint-Étienne
country: France
facility: Hôpital Nord
city: Strasbourg
country: France
facility: Chu de Strasbourg
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Chu de Toulouse
city: Tours
country: France
facility: CHRU de Tours
city: Tours
country: France
facility: Clinique Cardiologique Saint Gatien
city: Villeurbanne
country: France
facility: Clinique du Tonkin
Study officials:
affiliation: Hospices Civils de Lyon
name: JEAN FRANCOIS OBADIA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.