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Edwards EVOQUE Eos MISCEND Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Nov 25, 2024, no change to tracked fieldsv21-v22
  2. Primary completion date: Dec 31, 2023 to Apr 30, 2028 Completion date: Dec 31, 2028 to Apr 30, 2033v20 Show 1 more changeShow less
    • Completion date: Dec 31, 2028 to Apr 30, 2033
  3. Primary completion date: Dec 2023 to Dec 31, 2023 Completion date: Dec 2028 to Dec 31, 2028 · Start date: Feb 2015 to Feb 6, 2015v19 Show 2 more changesShow less
    • Completion date: Dec 2028 to Dec 31, 2028
    • Start date: Feb 2015 to Feb 6, 2015
  4. Trial status: Recruiting to Active, Not Recruiting Site details revised at 19 of 19 sitesv18 Show 1 more changeShow less
    • Site details revised at 19 of 19 sites
  5. Primary completion date: Dec 2022 to Dec 2023 Enrollment target: 103 to 123 · Completion date: Dec 2027 to Dec 2028 · Site details revised at 3 of 19 sitesv17 Show 3 more changesShow less
    • Enrollment target: 103 to 123
    • Completion date: Dec 2027 to Dec 2028
    • Site details revised at 3 of 19 sites
Show 15 earlier versionsHide 15 earlier versions
  1. Enrollment target: 83 to 103 Study sites: 18 to 19v16 Show 1 more changeShow less
    • Study sites: 18 to 19
  2. Enrollment target: 58 to 83v15
  3. Study sites: 17 to 18v14
  4. Primary completion date: Dec 2024 to Dec 2022 Primary endpoint revised · Completion date: Dec 2024 to Dec 2027 · Interventions: Edwards EVOQUE Transcatheter Mitral Valve Replacement System (Device) to Edwards EVOQUE Eos Mitral Valve Replacement System (Device) · 4 morev13 Show 7 more changesShow less
    • Primary endpoint revised
    • Completion date: Dec 2024 to Dec 2027
    • Interventions: Edwards EVOQUE Transcatheter Mitral Valve Replacement System (Device) to Edwards EVOQUE Eos Mitral Valve Replacement System (Device)
    • Secondary endpoints: 3 to 6
    • Study description revised
    • Site details revised at 11 of 17 sites
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 1 of 17 sitesv12
  6. Primary completion date: Dec 2019 to Dec 2024 Study sites: 16 to 17v11 Show 1 more changeShow less
    • Study sites: 16 to 17
  7. Site details revised at 4 of 16 sitesv10
  8. Study sites: 14 to 16v9
  9. Study sites: 13 to 14v8
  10. Enrollment target: 30 to 58 Primary completion date: Jun 2018 to Dec 2019 · Study sites: 11 to 13 · Completion date: Jun 2022 to Dec 2024 · 3 morev7 Show 6 more changesShow less
    • Primary completion date: Jun 2018 to Dec 2019
    • Study sites: 11 to 13
    • Completion date: Jun 2022 to Dec 2024
    • Interventions: Transcatheter Mitral Valve Replacement (TMVR) (Device) to Edwards EVOQUE Transcatheter Mitral Valve Replacement System (Device)
    • Study description shortened, about 4 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. Phase: Phase 1 to Not applicable Enrollment target: 28 to 30 · Study sites: 10 to 11 · Primary completion date: Dec 2017 to Jun 2018 · 4 morev6 Show 7 more changesShow less
    • Enrollment target: 28 to 30
    • Study sites: 10 to 11
    • Primary completion date: Dec 2017 to Jun 2018
    • Completion date: Dec 2021 to Jun 2022
    • Eligibility criteria revised
    • Study title shortened, about 6 words
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 9 to 10v5
  13. Primary completion date: Dec 2016 to Dec 2017 Study sites: 6 to 9v4 Show 1 more changeShow less
    • Study sites: 6 to 9
  14. Study sites: 7 to 6v3
  15. Site details revised at 1 of 7 sitesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system
Trial Details
NCT Number NCT02718001
Lead Sponsor Edwards Lifesciences
Conditions Mitral Valve Regurgitation (Degenerative or Functional)
Enrollment 123 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov