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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 : Unknown
Verified September 2015 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : August 12, 2013
Last Update Posted : September 22, 2015
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.
Study Start Date : November 2013
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

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
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

Inclusion Criteria:

  • Age > 18 years old
  • Severe secondary mitral regurgitation confirmed by the Echocardiography Core Laboratory
  • Characterized by a regurgitation volume > 30 mL/beat or a regurgitant orifice area > 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
  • Assessed by the investigator to be on optimal standard of care therapy for heart failure
  • Assessed by the heart team to be not eligible to a mitral surgery intervention

Exclusion Criteria:

  • Primary mitral regurgitation
  • Myocardial infarction or coronary bypass grafting surgery within 3 months prior to randomization
  • Cardiac resynchronization therapy within 3 months prior to randomization
  • Cardioversion within 3 months prior to randomization
  • Need for any cardiovascular surgery (including registration on cardiac transplant list)
  • Coronary angioplasty within 1 month prior to randomization
  • History of mitral valve repair
  • Active infection requiring current antibiotic therapy
  • Terminal renal insufficiency (renal replacement therapy)
  • Severe hepatic insufficiency
  • Evidence of stroke within 3 months prior to randomization
  • Concurrent medical condition with a life expectancy of less than 12 months
  • Uncontrolled hypertension
  • Known hypersensitivity to nitinol
  • Currently participating in another trial
  • Pregnant women

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

Contact: JEAN FRANCOIS OBADIA, MD 472357247 ext +33 jean-francois.obadia@chu-lyon.fr
Contact: Nathan MEWTON, MD 427856687 ext +33 nathan.mewton@chu-lyon.fr

CHU d'Angers Not yet recruiting
Angers, France, 49933
Contact: ALAIN FURBER, PU-PH         
Principal Investigator: ALAIN FURBER, PU-PH         
Chu de Besancon Recruiting
Besancon, France
Contact: SYDNEY CHOCRON, Pr         
Principal Investigator: Sydney Chocron, Pr         
Chu de Bordeaux Recruiting
Bordeaux, France
Contact: LIONEL LEROUX, MD         
Principal Investigator: LIONEL LEROUX, MD         
CHRU La Cavale Blanche Not yet recruiting
Brest, France
Contact: Martine Gilard, PU-PH         
Principal Investigator: Martine Gilard, PU-PH         
Groupement Hospitalier Est Recruiting
Bron, France
Contact: JEAN FRANCOIS OBADIA, MD         
Principal Investigator: JEAN FRANCOIS BADIA, Pr         
CHU Caen Not yet recruiting
Caen, France, 14000
Contact: FARZIN BEYGUI, MD         
Principal Investigator: FARZIN BEYGUI, MD         
Hôpital Gabriel Montpied Recruiting
Clermont Ferrand, France, 63000
Contact: PASCAL MOTREFF, PH         
Principal Investigator: PASCAL MOTREFF, PH         
APHP Hôpital Henri Mondor Recruiting
Creteil, France
Contact: EMMANUEL TEIGER         
Principal Investigator: EMMANUEL TEIGER, Pr         
CHU de Grenoble Recruiting
Grenoble, France, 38700
Contact: BERNARD BERTRAND, PH         
Principal Investigator: BERNARD BERTRAND, PH         
Hôpital privé de Parly 2 Recruiting
Le Chesnay, France, 78150
Contact: CLAUDE VAISLIC, MD         
Principal Investigator: CLAUDE VAISLIC, MD         
Centre Chirurgical Marie Lannelongue Recruiting
Le Plessis Robinson, France
Contact: ALEXANDRE AZMOUN, MD         
Principal Investigator: ALEXANDRE AZMOUN, MD         
Chu de Lille Not yet recruiting
Lille, France
Contact: ALAIN PRAT, PR         
Principal Investigator: ALAIN PRAT, Pr         
Hôpital Saint-Joseph Recruiting
Marseille, France, 13285
Contact: REMI HOUEL, MD         
Principal Investigator: REMI HOUEL, MD         
Hopital de La Timone Recruiting
Marseille, France
Contact: JEAN LOUIS BONNET, Pr         
Principal Investigator: JEAN-LOUIS BONNET, PR         
Institut Hospitalier Jacques Cartier Recruiting
Massy, France
Contact: THIERRY LEFEVRE, MD         
Principal Investigator: THIERRY LEFEVRE, MD         
CH Annecy Genevois Not yet recruiting
Metz-Tessy, France, 74370
Contact: LOIC BELLE, MD         
Principal Investigator: LOIC BELLE, MD         
Chu de Montpellier Recruiting
Montpellier, France
Contact: FLORENCE LECLERCQ, PR         
Principal Investigator: FLORENCE LECLERCQ, PR         
Clinique Du Millenaire Not yet recruiting
Montpellier, France
Contact: CHRISTOPHE PIOT, MD         
Principal Investigator: CHRISTOPHE PIOT, MD         
Chu de Nancy Not yet recruiting
Nancy, France
Contact: YVES JUILLIERE, PR         
Principal Investigator: YVES JUILLIERE, PR         
Chu de Nantes Recruiting
Nantes, France
Contact: PATRICE GUERIN, PR         
Principal Investigator: PATRICE GUERIN, PR         
Centre chirurgicale Ambroise Paré Not yet recruiting
Neuilly Sur Seine, France, 92200
Contact: Olivier Belliard, MD         
Principal Investigator: Olivier Belliard, MD         
Groupe Hospitalier La Salpétrière Not yet recruiting
Paris, France, 75013
Contact: Jean-Philippe Collet, PU-PH         
Principal Investigator: Jean-Philippe Collet, PU-PH         
Institut Mutualiste Montsouris Not yet recruiting
Paris, France, 75014
Contact: Christophe CAUSSIN, MD         
Principal Investigator: Christophe CAUSSIN, MD         
Hôpital Européen Georges Pompidou Not yet recruiting
Paris, France, 75015
Contact: Christian Spaulding, PU-PH         
Principal Investigator: Christian Spaulding, PU-PH         
Aphp Hopital Bichat Recruiting
Paris, France
Contact: ALEC VAHANIAN, PR         
Principal Investigator: ALEC VAHANIAN, PR         
Chu de Rennes Recruiting
Rennes, France
Contact: MARC BEDOSSA, MD         
Principal Investigator: MARC BEDOSSA, MD         
CHU Rouen Not yet recruiting
Rouen, France
Contact: Hélène ELTCHANINOFF, PU-PH         
Principal Investigator: Hélène ELTCHANINOFF, PU-PH         
Chu de Strasbourg Recruiting
Strasbourg, France
Contact: PATRICK OHLMANN, PR         
Principal Investigator: PATRICK OHLMANN, PR         
Clinique Pasteur Not yet recruiting
Toulouse, France, 31076
Contact: DIDIER TCHETCHE, MD         
Principal Investigator: DIDIER TCHETCHE, MD         
Chu de Toulouse Recruiting
Toulouse, France
Contact: NICOLAS DUMONTEIL, MD         
Principal Investigator: NICOLAS DUMONTEIL, MD         
CHRU de Tours Not yet recruiting
Tours, France
Contact: Christophe SAINT ETIENNE, PH         
Principal Investigator: Christophe SAINT ETIENNE, PH         
Clinique du Tonkin Not yet recruiting
Villeurbanne, France
Contact: Fabrice Wautot, MD         
Principal Investigator: Fabrice Wautot, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
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: September 22, 2015
Last Verified: September 2015

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