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

This study is currently recruiting participants.
Verified March 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01920698
First received: August 8, 2013
Last updated: April 1, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Cardiovascular Diseases
Device: Percutaneous MitraClip Device Implantation
Other: control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentre Randomized Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation.

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • All-cause mortality and unplanned hospitalizations for heart failure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

  • Change in Quality of Life score as measured by the European Quality of Life-5 Dimensions instrument. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Change in functional evaluation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in echocardiographic evaluation between baseline and 6 and 12 months. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Change in biomarkers (BNP levels, creatinine) at 6 months and 12 months [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Cost-effectiveness of each strategy at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 288
Study Start Date: November 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Severe secondary mitral regurgitation confirmed by the Echocardiography Core Laboratory
  • Characterized by a regurgitation volume > 30 mL/beat and 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01920698

Contacts
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

Locations
France
Chu de Besancon Not yet recruiting
Besancon, France
Contact: SYDNEY CHOCRON, Pr         
Principal Investigator: Sydney Chocron, Pr         
Chu de Bordeaux Not yet recruiting
Bordeaux, France
Contact: LIONEL LEROUX, MD         
Principal Investigator: LIONEL LEROUX, MD         
Groupement Hospitalier Est Recruiting
Bron, France
Contact: JEAN FRANCOIS OBADIA, MD         
Principal Investigator: JEAN FRANCOIS BADIA, Pr         
APHP Hôpital Henri Mondor Not yet recruiting
Creteil, France
Contact: EMMANUEL TEIGER         
Principal Investigator: EMMANUEL TEIGER, Pr         
Centre Chirurgical Marie Lannelongue Not yet recruiting
Le Plessis Robinson, France
Contact: CHRISTOPHE CAUSSIN, MD         
Principal Investigator: CHRISTOPHE CAUSSIN, MD         
Chu de Lille Not yet recruiting
Lille, France
Contact: ALAIN PRAT, PR         
Principal Investigator: ALAIN PRAT, Pr         
Hopital de La Timone Recruiting
Marseille, France
Contact: JEAN LOUIS BONNET, Pr         
Principal Investigator: FREDERIC COLLART, PR         
Institut Hospitalier Jacques Cartier Not yet recruiting
Massy, France
Contact: THIERRY LEFEVRE, MD         
Principal Investigator: THIERRY LEFEVRE, MD         
Chu de Montpellier Not yet 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         
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 de Strasbourg Not yet recruiting
Strasbourg, France
Contact: PATRICK OHLMANN, PR         
Principal Investigator: PATRICK OHLMANN, PR         
Chu de Toulouse Not yet recruiting
Toulouse, France
Contact: NICOLAS DUMONTEIL, MD         
Principal Investigator: NICOLAS DUMONTEIL, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: JEAN FRANCOIS OBADIA, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01920698     History of Changes
Other Study ID Numbers: 2013.798
Study First Received: August 8, 2013
Last Updated: April 1, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on April 17, 2014