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Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Study acronym: CLASP II TR
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 54 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 79 sitesv54
  2. Site contacts updated at 1 of 79 sitesv53
  3. Site details revised at 4 of 79 sitesv52
  4. Enrollment increased: 870 → 1270 participants Site details revised at 2 of 79 sitesv51 Show 1 more changeShow less
    • Site details revised at 2 of 79 sites
  5. Secondary endpoints: 14 to 15v50 See this version in full on ClinicalTrials.gov ↗
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 1 of 79 sitesv49
  2. Site details revised at 1 of 79 sitesv48
  3. Site contacts updated at 1 of 79 sitesv47
  4. Re-verified, no change to tracked fieldsv46
  5. Site contacts updated at 1 of 79 sitesv45
  6. Site details revised at 1 of 79 sitesv44
  7. Re-verified, no change to tracked fieldsv43
  8. Site contacts updated at 1 of 79 sitesv42
  9. Site details revised at 2 of 79 sitesv41
  10. Site details revised at 1 of 79 sitesv40
  11. Site details revised at 2 of 79 sitesv39
  12. Site details revised at 2 of 79 sitesv38
  13. Site contacts updated at 1 of 79 sitesv37
  14. Re-verified, no change to tracked fieldsv36
  15. Site details revised at 20 of 79 sitesv35
  16. Site contacts updated at 1 of 79 sitesv34
  17. Primary completion date: Dec 31, 2024 to Dec 31, 2027 Completion date: Mar 31, 2029 to Dec 31, 2031 · Interventions: Edwards PASCAL System (Device), Edwards PASCAL System (Device), Optimal Medical Therapy (Drug) to Edwards PASCAL System (Device), Edwards PASCAL System (Device), Edwards PASCAL System (Device), Optimal Medical Therapy (Drug) · Secondary endpoints: 13 to 14 · 1 morev33 Show 4 more changesShow less
    • Completion date: Mar 31, 2029 to Dec 31, 2031
    • Interventions: Edwards PASCAL System (Device), Edwards PASCAL System (Device), Optimal Medical Therapy (Drug) to Edwards PASCAL System (Device), Edwards PASCAL System (Device), Edwards PASCAL System (Device), Optimal Medical Therapy (Drug)
    • Secondary endpoints: 13 to 14
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  18. Site contacts updated at 2 of 79 sitesv32
  19. Site contacts updated at 1 of 79 sitesv31
  20. Study sites: 78 to 79v30
  21. Site contacts updated at 1 of 78 sitesv29
  22. Site details revised at 1 of 78 sitesv28
  23. Site details revised at 1 of 78 sitesv27
  24. Site details revised at 1 of 78 sitesv26
  25. Study sites: 77 to 78v25
  26. Site details revised at 1 of 77 sitesv24
  27. Study sites: 76 to 77v23
  28. Study sites: 75 to 76v22
  29. Study sites: 74 to 75v21
  30. Study sites: 72 to 74v20
  31. Study sites: 69 to 72v19
  32. Enrollment target: 825 to 870 Primary completion date: Dec 2024 to Dec 31, 2024 · Completion date: Mar 2029 to Mar 31, 2029 · Eligibility criteria expanded, about 12 words · 2 morev18 Show 5 more changesShow less
    • Primary completion date: Dec 2024 to Dec 31, 2024
    • Completion date: Mar 2029 to Mar 31, 2029
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints revised (13)
    • Study sites revised (69)

    See this version in full on ClinicalTrials.gov ↗

  33. Study sites: 65 to 69v17
  34. Study sites: 59 to 65v16
  35. Study sites: 56 to 59v15
  36. Study sites: 48 to 56v14
  37. Eligibility criteria expanded, about 183 wordsv13 See this version in full on ClinicalTrials.gov ↗
  38. Primary completion date: Aug 2022 to Dec 2024 Study sites: 44 to 48 · Completion date: Mar 2027 to Mar 2029 · Interventions: Edwards PASCAL System (Device), Optimal Medical Therapy (Drug) to Edwards PASCAL System (Device), Edwards PASCAL System (Device), Optimal Medical Therapy (Drug) · 1 morev12 Show 4 more changesShow less
    • Study sites: 44 to 48
    • Completion date: Mar 2027 to Mar 2029
    • Interventions: Edwards PASCAL System (Device), Optimal Medical Therapy (Drug) to Edwards PASCAL System (Device), Edwards PASCAL System (Device), Optimal Medical Therapy (Drug)
    • Study arms: 2 to 3
  39. Study sites: 41 to 44v11
  40. Study sites: 35 to 41v10
  41. Study sites: 33 to 35v9
  42. Study sites: 16 to 33v8
  43. Site details revised at 3 of 16 sitesv7
  44. Trial status: Active, Not Recruiting to Recruiting Study sites: 10 to 16v6 Show 1 more changeShow less
    • Study sites: 10 to 16
  45. Trial status: Recruiting to Active, Not Recruiting Study sites: 3 to 10v5 Show 1 more changeShow less
    • Study sites: 3 to 10
  • 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 Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team
Trial Details
NCT Number NCT04097145
Lead Sponsor Edwards Lifesciences
Conditions Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
Enrollment 1,270 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov