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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 : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation (Degenerative or Functional) Device: Edwards EVOQUE Eos Mitral Valve Replacement System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device (MISCEND)
Study Start Date : February 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2027

Arm Intervention/treatment
Experimental: Treatment
Treatment with the Edwards EVOQUE Eos mitral valve replacement system
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




Primary Outcome Measures :
  1. Composite of major adverse events [ Time Frame: 30 days ]
    Proportion of patients with major adverse events


Secondary Outcome Measures :
  1. NYHA functional class [ Time Frame: 30 days, 6 Months, 12 Months, annual for five years ]
    Number of patients with improvement in NYHA class

  2. Six minute walk test [ Time Frame: 30 days, 6 Months, 12 Months, annual for five years ]
    Increase in distance (m) from baseline

  3. 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

  4. Device Success [ Time Frame: Immediately after procedure ]
    Proportion of patients with device deployed as intended and delivery system successfully retrieved

  5. Procedural Success [ Time Frame: Discharge or 7 days post-procedure, whichever occurs first ]
    Proportion of patients with device success without significant paravalvular leak

  6. Clinical Success [ Time Frame: 30 days ]
    Proportion of patients with procedural success without major adverse events



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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:

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

Exclusion Criteria:

  • Unsuitable anatomy
  • Patient is inoperable

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): NCT02718001


Contacts
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Contact: TMTT Clinical (949) 250-2500 TMTT_Clinical@edwards.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Rajendra Makkar, MD Cedars-Sinai Medical Center, Los Angeles, CA
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02718001    
Other Study ID Numbers: 2013-05C
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
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
Transseptal
Trans-Septal
Transeptal
Severe
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases