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

Cardiovascular Diseases Clinical Trial

— MITRA-FR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01920698
• Other study ID #: 2013.798
• Secondary ID: 2013-A00464-41
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 2013
• Est. completion date: April 2019

Study information

• Verified date: July 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 288
• Est. completion date: April 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Mitral Valve Insufficiency

Intervention

Device:
• Percutaneous MitraClip Device Implantation
MitraClip System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system

Other:
• control

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	Chu de Besancon	Besancon
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	Creteil
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	Hopital de La Timone	Marseille
France	Hôpital privé Clairval	Marseille
France	Hôpital Saint-Joseph	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	Aphp Hopital Bichat	Paris
France	Groupe Hospitalier La Salpétrière	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Institut Mutualiste Montsouris	Paris
France	CHRU La Milétrie	Poitiers
France	Chu de Rennes	Rennes
France	CHU Rouen	Rouen
France	Centre Cardiologique du Nord	Saint Denis
France	Institut Arnault Tzanck	Saint Laurent Du Var
France	Hôpital Nord	Saint-Étienne
France	Chu de Strasbourg	Strasbourg
France	Chu de Toulouse	Toulouse
France	Clinique Pasteur	Toulouse
France	CHRU de Tours	Tours
France	Clinique Cardiologique Saint Gatien	Tours
France	Clinique du Tonkin	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality and unplanned hospitalizations for heart failure		1 year
Secondary	All-cause mortality, cardiac mortality		30 days, 6 months, 12 months, and 24 months.
Secondary	Survival with no major cardiovascular events		30 days, 6 months, 12 months, and 24 months.
Secondary	Serious Adverse Events	Any serious adverse events cardiovascular or not occurring within each group.	30 days, 6 months, 12 months and 24 months.
Secondary	Change in Quality of Life score as measured by the European Quality of Life-5 Dimensions instrument.		6 months and 12 months
Secondary	Change in functional evaluation		12 months
Secondary	Change in echocardiographic evaluation between baseline at 6, 12 and 24 months.		6 months, 12 months and 24 months
Secondary	Change in biomarkers (BNP levels, creatinine) at 6 months and 12 months		6 months and 12 months
Secondary	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.	12 months