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CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study (RELIEF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02722551
Recruitment Status : Withdrawn
First Posted : March 30, 2016
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief Summary:
Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve Phase 1 Phase 2

Detailed Description:
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve with transapical and transseptal delivery systems in patients with degenerative or functional/ischemic mitral regurgitation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The RELIEF Trial: REduction or eLimination of mItral rEgurgitation in Degenerative or Functional Mitral Regurgitation With the CardiAQ-Edwards™ Transcatheter Mitral Valve
Study Start Date : November 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Treatment with the CardiAQ-Edwards™ Transcatheter Mitral Valve (transapical or transseptal delivery)
 Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve
Replacement of the mitral valve through a transcatheter approach


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from major adverse cardiac and cerebrovascular events [ Time Frame: 30 days ]
    MACCE; all-cause mortality, myocardial infarction, stroke, renal failure, and conversion to surgery per MVARC definitions

  2. Freedom from individual adverse events [ Time Frame: 30 days ]
    % Freedom from individual adverse events


Secondary Outcome Measures :
  1. New York Heart Association (NYHA) functional class [ Time Frame: 30 days, 3 months, 6 months, 12 months ]
    Number of patients with improvement in NYHA class

  2. Six minute walk test: [ Time Frame: 30 days, 3 months, 6 months, 12 months ]
    Increase in distance (m) from baseline

  3. Reduction in mitral regurgitation (MR) grade: [ Time Frame: 30 days, 3 months, 6 months, 12 months ]
    Number of patients with reduction in MR grade from baseline

  4. Technical success [ Time Frame: 30 days, 3 months, 6 months, 12 months ]
    Technical success per MVARC criteria (%)

  5. Device success [ Time Frame: 30 days, 3 months, 6 months, 12 months ]
    Device success per MVARC criteria (%)

  6. Procedure success [ Time Frame: 30 days, 3 months, 6 months, 12 months ]
    Procedure success per MVARC criteria (%)

  7. Patient success [ Time Frame: 30 days, 3 months, 6 months, 12 months ]
    Patient success per MVARC criteria (%)


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

Inclusion Criteria:

  • NYHA ≥ II
  • Moderate/severe or severe mitral regurgitation
  • Prohibitive risk for open-heart surgery
  • Meets anatomical criteria

Exclusion Criteria:

  • Unsuitable anatomy
  • Need for emergent or urgent surgery
  • Prior mechanical aortic valve replacement
  • Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve
  • Preexisting device in the left ventricular apex
  • Clinically significant, untreated coronary artery disease
  • Limited life expectancy (< 12 months)
  • Active infection
Contacts and Locations
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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): NCT02722551


Locations
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Canada, British Columbia
St. Paul's Hospital, University of British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Centre Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada
Centre de recherche Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)
Quebec, Canada, G1V 4G5
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
France
Centre Hospitalier Régional Universitaire de Lille
Lille, France, 59000
Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany, 61231
Deutsche Herzzentrum Berlin
Berlin, Germany, 13353
University Heart Centre
Hamburg, Germany, 20146
Herzzentrum der UniKlinik Köln
Köln, Germany, 50937
Leipzig Herzzentrum
Leipzig, Germany, 04289
Italy
Ospedale San Raffaele
Milano, Italy, 20132
Universita di Roma Tor Vergata
Roma, Italy, 00133
Netherlands
Erasmus Medical Centre
Rotterdam, Netherlands, 3015 CE
Switzerland
InselSpital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Lars Sondergaard The Rigshospitalet, Copenhagen, Denmark
More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02722551    
Other Study ID Numbers: 2015-14
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Edwards Lifesciences:
Mitral
Regurgitation
Insufficiency
Degenerative
Functional
Primary
Secondary
Organic
Transcatheter
 TMVR
TMVI
Heart valve
Mitral valve
Transapical
Transfemoral
Transeptal
Severe
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases