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Edwards EVOQUE Eos MISCEND Study

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ClinicalTrials.gov Identifier: NCT02718001
Recruitment Status : Recruiting
First Posted : March 24, 2016
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE March 1, 2016
First Posted Date  ICMJE March 24, 2016
Last Update Posted Date June 15, 2021
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2021)
Composite of major adverse events [ Time Frame: 30 days ]
Proportion of patients with major adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
Safety assessed by freedom from device or procedure-related adverse events [ Time Frame: 30 days ]
Safety assessed by freedom from device- or procedure-related adverse events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2021)
  • NYHA functional class [ Time Frame: 30 days, 6 Months, 12 Months, annual for five years ]
    Number of patients with improvement in NYHA class
  • Six minute walk test [ Time Frame: 30 days, 6 Months, 12 Months, annual for five years ]
    Increase in distance (m) from baseline
  • Reduction in MR grade [ Time Frame: 30 days, 6 Months, 12 Months, annual for five years ]
    Number of patients with reduction in MR grade from baseline
  • Device Success [ Time Frame: Immediately after procedure ]
    Proportion of patients with device deployed as intended and delivery system successfully retrieved
  • Procedural Success [ Time Frame: Discharge or 7 days post-procedure, whichever occurs first ]
    Proportion of patients with device success without significant paravalvular leak
  • Clinical Success [ Time Frame: 30 days ]
    Proportion of patients with procedural success without major adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
  • NYHA functional class [ Time Frame: 30 days, 3 Months ,6 Months, 12 Months, annual for five years ]
    Number of patients with improvement in NYHA class
  • Six minute walk test [ Time Frame: 30 days, 3 Months ,6 Months, 12 Months, annual for five years ]
    Increase in distance (m) from baseline
  • Reduction in MR grade [ Time Frame: 30 days, 3 Months ,6 Months, 12 Months, annual for five years ]
    Number of patients with reduction in MR grade from baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Edwards EVOQUE Eos MISCEND Study
Official Title  ICMJE Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device (MISCEND)
Brief Summary Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system
Detailed Description The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mitral Valve Regurgitation (Degenerative or Functional)
Intervention  ICMJE Device: Edwards EVOQUE Eos Mitral Valve Replacement System
Replacement of the mitral valve through a transcatheter approach
Other Names:
  • CardiAQ-Edwards™ Transcatheter Mitral Valve (TMV)
  • Edwards FORTIS™ Transcatheter Mitral Valve (TMV)
  • Transcatheter Mitral Valve Replacement (TMVR)
  • Edwards EVOQUE Transcatheter Mitral Valve Replacement System
Study Arms  ICMJE Experimental: Treatment
Treatment with the Edwards EVOQUE Eos mitral valve replacement system
Intervention: Device: Edwards EVOQUE Eos Mitral Valve Replacement System
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2019)
58
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2016)
28
Estimated Study Completion Date  ICMJE December 2027
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinically significant, symptomatic mitral regurgitation
  • High risk for open-heart surgery
  • Meets anatomical criteria

Exclusion Criteria:

  • Unsuitable anatomy
  • Patient is inoperable
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: TMTT Clinical (949) 250-2500 TMTT_Clinical@edwards.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02718001
Other Study ID Numbers  ICMJE 2013-05C
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: Rajendra Makkar, MD Cedars-Sinai Medical Center, Los Angeles, CA
PRS Account Edwards Lifesciences
Verification Date June 2021

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