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Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

Study acronym: CLASP IID/IIF
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 51 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 86 → 81 locationsv51
  2. Re-verified, no change to tracked fieldsv50
  3. Study sites: 87 to 86v49
  4. Trial status: Recruiting to Active, Not Recruiting Study sites: 103 to 87v48 Show 1 more changeShow less
    • Study sites: 103 to 87
  5. Study sites: 102 to 103v47
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 2 of 102 sitesv46
  2. Primary completion date: Jan 31, 2025 to Jun 30, 2026 Study sites: 100 to 102 · Completion date: Apr 30, 2030 to Jun 30, 2031v45 Show 2 more changesShow less
    • Study sites: 100 to 102
    • Completion date: Apr 30, 2030 to Jun 30, 2031
  3. Site details revised at 21 of 100 sitesv44
  4. Study sites: 99 to 100v43
  5. Site contacts updated at 3 of 99 sitesv42
  6. Study sites: 100 to 99v41
  7. Site contacts updated at 2 of 100 sitesv40
  8. Site details revised at 3 of 100 sitesv39
  9. Study sites: 99 to 100v38
  10. Primary completion date: Dec 31, 2023 to Jan 31, 2025 Completion date: Jan 31, 2028 to Apr 30, 2030v37 Show 1 more changeShow less
    • Completion date: Jan 31, 2028 to Apr 30, 2030
  11. Study sites: 97 to 99v36
  12. Study sites: 96 to 97v35
  13. Study sites: 95 to 96v34
  14. Enrollment target: 1275 to 1247 Eligibility criteria expanded, about 22 wordsv33 Show 1 more changeShow less
    • Eligibility criteria expanded, about 22 words

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 93 to 95v32
  16. Study arms: 4 to 5v31
  17. Study sites: 92 to 93v30
  18. Study sites revised (92)v29 See this version in full on ClinicalTrials.gov ↗
  19. Study sites: 89 to 92v28
  20. Study sites: 87 to 89v27
  21. Study sites: 85 to 87v26
  22. Study sites: 82 to 85v25
  23. Site details revised at 2 of 82 sitesv24
  24. Study sites: 79 to 82v23
  25. Study sites: 77 to 79v22
  26. Study sites: 75 to 77v21
  27. Phase: Phase 3 to Not applicable Primary endpoints revised (3) · Study sites: 73 to 75 · Secondary endpoints: 4 to 5 · 1 morev20 Show 4 more changesShow less
    • Primary endpoints revised (3)
    • Study sites: 73 to 75
    • Secondary endpoints: 4 to 5
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  28. Study sites: 72 to 73v19
  29. Study sites: 67 to 72v18
  30. Study sites: 64 to 67v17
  31. Study sites: 63 to 64v16
  32. Study sites: 61 to 63v15
  33. Trial status: Active, Not Recruiting to Recruiting Study sites: 57 to 61v14 Show 1 more changeShow less
    • Study sites: 57 to 61
  34. Trial status: Recruiting to Active, Not Recruiting Study sites: 49 to 57v13 Show 1 more changeShow less
    • Study sites: 49 to 57
  35. Study sites: 43 to 49v12
  36. Study sites: 35 to 43v11
  37. Study sites: 31 to 35v10
  38. Study sites: 29 to 31v9
  39. Study sites: 24 to 29v8
  40. Enrollment target: 675 to 1275 Primary completion date: Jun 30, 2021 to Dec 31, 2023 · Primary endpoints: 2 to 3 · Study sites: 12 to 24 · 5 morev7 Show 8 more changesShow less
    • Primary completion date: Jun 30, 2021 to Dec 31, 2023
    • Primary endpoints: 2 to 3
    • Study sites: 12 to 24
    • Completion date: Jul 31, 2026 to Jan 31, 2028
    • Eligibility criteria expanded, about 55 words
    • Study description expanded, about 12 words
    • Study title revised
    • Study arms: 2 to 4

    See this version in full on ClinicalTrials.gov ↗

  41. Study sites: 9 to 12v6
  42. Study sites: 5 to 9v5
  43. Study sites: 2 to 5v4
  44. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Nov 1, 2018 to Nov 30, 2018v3 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Nov 1, 2018 to Nov 30, 2018
  45. Lead sponsor: [Redacted] to Edwards Lifesciences Trial status: Withheld to Not Yet Recruiting · Primary completion date: Jun 30, 2021 · Completion date: Jul 31, 2026 · 2 morev2 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Jun 30, 2021
    • Completion date: Jul 31, 2026
    • Start date: Nov 1, 2018
    • Study title shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  • 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.
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Trial Details
NCT Number NCT03706833
Lead Sponsor Edwards Lifesciences
Conditions Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
Enrollment 1,247 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov