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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Recruitment Status : Withdrawn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

Tracking Information
First Submitted Date  ICMJE March 1, 2016
First Posted Date  ICMJE March 30, 2016
Last Update Posted Date January 9, 2018
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2016)
  • 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
  • Freedom from individual adverse events [ Time Frame: 30 days ]
    % Freedom from individual adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02722551 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2016)
  • 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
  • Six minute walk test: [ Time Frame: 30 days, 3 months, 6 months, 12 months ]
    Increase in distance (m) from baseline
  • 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
  • Technical success [ Time Frame: 30 days, 3 months, 6 months, 12 months ]
    Technical success per MVARC criteria (%)
  • Device success [ Time Frame: 30 days, 3 months, 6 months, 12 months ]
    Device success per MVARC criteria (%)
  • Procedure success [ Time Frame: 30 days, 3 months, 6 months, 12 months ]
    Procedure success per MVARC criteria (%)
  • Patient success [ Time Frame: 30 days, 3 months, 6 months, 12 months ]
    Patient success per MVARC criteria (%)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study
Official Title  ICMJE The RELIEF Trial: REduction or eLimination of mItral rEgurgitation in Degenerative or Functional Mitral Regurgitation With the CardiAQ-Edwards™ Transcatheter Mitral Valve
Brief Summary Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mitral Valve Regurgitation
Intervention  ICMJE Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve
Replacement of the mitral valve through a transcatheter approach
Study Arms  ICMJE Experimental: Treatment
Treatment with the CardiAQ-Edwards™ Transcatheter Mitral Valve (transapical or transseptal delivery)
Intervention: Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 5, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2016)
200
Estimated Study Completion Date  ICMJE October 2024
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   France,   Germany,   Italy,   Netherlands,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02722551
Other Study ID Numbers  ICMJE 2015-14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Edwards Lifesciences
Study Sponsor  ICMJE Edwards Lifesciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lars Sondergaard The Rigshospitalet, Copenhagen, Denmark
PRS Account Edwards Lifesciences
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP