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Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR)

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ClinicalTrials.gov Identifier: NCT01920698
Recruitment Status : Active, not recruiting
First Posted : August 12, 2013
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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).


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Device: Percutaneous MitraClip Device Implantation Other: control Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentre Randomized Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation.
Actual Study Start Date : November 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: MitraClip Device
Subjects randomized to the MitraClip Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy.
Device: 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
Other: control
Other Name: Patients randomized to the Control Group will receive optimal medical therapy alone



Primary Outcome Measures :
  1. All-cause mortality and unplanned hospitalizations for heart failure [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. All-cause mortality, cardiac mortality [ Time Frame: 30 days, 6 months, 12 months, and 24 months. ]
  2. Survival with no major cardiovascular events [ Time Frame: 30 days, 6 months, 12 months, and 24 months. ]
  3. Serious Adverse Events [ Time Frame: 30 days, 6 months, 12 months and 24 months. ]
    Any serious adverse events cardiovascular or not occurring within each group.

  4. Change in Quality of Life score as measured by the European Quality of Life-5 Dimensions instrument. [ Time Frame: 6 months and 12 months ]
  5. Change in functional evaluation [ Time Frame: 12 months ]
  6. Change in echocardiographic evaluation between baseline at 6, 12 and 24 months. [ Time Frame: 6 months, 12 months and 24 months ]
  7. Change in biomarkers (BNP levels, creatinine) at 6 months and 12 months [ Time Frame: 6 months and 12 months ]
  8. Cost-effectiveness of each strategy at 12 months [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920698


Locations
France
CHU d'Angers
Angers, France, 49933
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, 14000
Hôpital Gabriel Montpied
Clermont Ferrand, France, 63000
APHP Hôpital Henri Mondor
Creteil, France
CHU de Grenoble
Grenoble, France, 38700
Hôpital privé de Parly 2
Le Chesnay, France, 78150
Centre Chirurgical Marie Lannelongue
Le Plessis Robinson, France
Chu de Lille
Lille, France
Hôpital privé le Bois
Lille, France
Hôpital Saint-Joseph
Marseille, France, 13285
Hopital de La Timone
Marseille, France
Hôpital privé Clairval
Marseille, France
Institut Hospitalier Jacques Cartier
Massy, France
CH Annecy Genevois
Metz-Tessy, France, 74370
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, 92200
Hôpital Pasteur
Nice, France, 06001
Groupe Hospitalier La Salpétrière
Paris, France, 75013
Institut Mutualiste Montsouris
Paris, France, 75014
Hôpital Européen Georges Pompidou
Paris, France, 75015
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
Institut Arnault Tzanck
Saint Laurent Du Var, France
Hôpital Nord
Saint-Étienne, France, 42055
Chu de Strasbourg
Strasbourg, France
Clinique Pasteur
Toulouse, France, 31076
Chu de Toulouse
Toulouse, France
CHRU de Tours
Tours, France
Clinique Cardiologique Saint Gatien
Tours, France
Clinique du Tonkin
Villeurbanne, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: JEAN FRANCOIS OBADIA, MD Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01920698     History of Changes
Other Study ID Numbers: 2013.798
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

Keywords provided by Hospices Civils de Lyon:
Heart Valve Diseases
Heart failure
Heart diseases
Mitral valve insufficiency

Additional relevant MeSH terms:
Cardiovascular Diseases
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases