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Clinical Study of Edwards Cardioband FIT Valve Repair System

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

Record History

  1. Re-verified, no change to tracked fieldsv25
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 11 to 9v24 Show 1 more changeShow less
    • Study sites: 11 to 9
  3. Site details revised at 1 of 11 sitesv23
  4. Enrollment target: 55 to 75v22
  5. Site details revised at 2 of 11 sitesv21
Show 19 earlier versionsHide 19 earlier versions
  1. Site details revised at 3 of 11 sitesv20
  2. Site details revised at 3 of 11 sitesv19
  3. Trial status: Active, Not Recruiting to Recruiting Site details revised at 11 of 11 sitesv18 Show 1 more changeShow less
    • Site details revised at 11 of 11 sites
  4. Primary completion date: Jan 31, 2025 to Dec 31, 2026 Primary endpoints: 1 to 3 · Completion date: Jan 31, 2030 to Dec 31, 2031 · Interventions: Transcatheter Tricuspid Valve Reconstruction (Device) to Transcatheter Tricuspid Valve Repair (Device) · 4 morev17 Show 7 more changesShow less
    • Primary endpoints: 1 to 3
    • Completion date: Jan 31, 2030 to Dec 31, 2031
    • Interventions: Transcatheter Tricuspid Valve Reconstruction (Device) to Transcatheter Tricuspid Valve Repair (Device)
    • Eligibility criteria expanded, about 344 words
    • Secondary endpoints shortened, about 6 words
    • Study title revised
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Jun 2023 to Jan 31, 2025 Trial status: Recruiting to Active, Not Recruiting · Completion date: Jun 2028 to Jan 31, 2030 · Site details revised at 11 of 11 sitesv16 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Jun 2028 to Jan 31, 2030
    • Site details revised at 11 of 11 sites
  6. Site details revised at 1 of 11 sitesv15
  7. Site details revised at 3 of 11 sitesv14
  8. Trial status: Active, Not Recruiting to Recruiting Primary endpoint revised · Study sites: 9 to 11 · Eligibility criteria expanded, about 23 words · 2 morev13 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 9 to 11
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: 4 to 3
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  9. Primary completion date: Jun 2021 to Jun 2023 Completion date: Jun 2026 to Jun 2028v12 Show 1 more changeShow less
    • Completion date: Jun 2026 to Jun 2028
  10. Enrollment target: 35 to 55 Primary completion date: Jun 2020 to Jun 2021 · Trial status: Recruiting to Active, Not Recruiting · Completion date: Jun 2024 to Jun 2026 · 1 morev11 Show 4 more changesShow less
    • Primary completion date: Jun 2020 to Jun 2021
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Jun 2024 to Jun 2026
    • Site details revised at 9 of 9 sites
  11. Site contacts updated at 1 of 9 sitesv10
  12. Study sites: 8 to 9v9
  13. Study sites: 7 to 8v8
  14. Site contacts updated at 1 of 7 sitesv7
  15. Re-verified, no change to tracked fieldsv6
  16. Enrollment target: 15 to 35 Study sites: 5 to 7v5 Show 1 more changeShow less
    • Study sites: 5 to 7
  17. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 5 · Start date changed from estimate of May 2018 to Jul 1, 2018v4 Show 2 more changesShow less
    • Study sites: 1 to 5
    • Start date changed from estimate of May 2018 to Jul 1, 2018
  18. Study sites: 0 to 1 Start date: Apr 2018 to May 2018v3 Show 1 more changeShow less
    • Start date: Apr 2018 to May 2018
  19. Primary endpoint revisedv2 See this version in full on ClinicalTrials.gov ↗
  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.
Clinical Study of the Edwards Cardioband FIT Repair System
Trial Details
NCT Number NCT03382457
Lead Sponsor Edwards Lifesciences
Conditions Tricuspid Regurgitation
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov