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Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy

Study acronym: PAS
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 72 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Mar 1, 2026 to Jul 2028 Trial status: Recruiting to Active, Not Recruiting · Study sites: 93 to 90v72 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 93 to 90
  2. Site details revised at 79 of 93 sitesv71
  3. Study sites: 95 to 93v70
  4. Study sites revised (95)v69 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 91 to 95v68
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 86 to 91v67
  2. Site contacts updated at 2 of 86 sitesv66
  3. Study sites revised (86)v65 See this version in full on ClinicalTrials.gov ↗
  4. Site details revised at 1 of 86 sitesv64
  5. Study sites: 82 to 86v63
  6. Primary endpoints: 2 to 3 Study sites: 62 to 82 · Eligibility criteria expanded, about 3 words · Secondary endpoints expanded, about 2 wordsv62 Show 3 more changesShow less
    • Study sites: 62 to 82
    • Eligibility criteria expanded, about 3 words
    • Secondary endpoints expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 61 to 62v61
  8. Study sites: 59 to 61v60
  9. Study sites: 57 to 59v59
  10. Study sites: 56 to 57v58
  11. Site contacts updated at 1 of 56 sitesv57
  12. Site contacts updated at 1 of 56 sitesv56
  13. Study sites: 55 to 56v55
  14. Site contacts updated at 2 of 55 sitesv54
  15. Primary and study completion dates: Dec 1, 2023 to Mar 1, 2026 Interventions: OPTIMIZER Smart (Device) to OPTIMIZER Smart System (Device) · Eligibility criteria shortened, about 85 words · Site contacts updated at 1 of 55 sitesv53 Show 3 more changesShow less
    • Interventions: OPTIMIZER Smart (Device) to OPTIMIZER Smart System (Device)
    • Eligibility criteria shortened, about 85 words
    • Site contacts updated at 1 of 55 sites

    See this version in full on ClinicalTrials.gov ↗

  16. Study sites: 54 to 55v52
  17. Study sites revised (54)v51 See this version in full on ClinicalTrials.gov ↗
  18. Study sites revised (54)v50 See this version in full on ClinicalTrials.gov ↗
  19. Study sites: 53 to 54v49
  20. Study sites: 52 to 53v48
  21. Site details revised at 1 of 52 sitesv47
  22. Study sites: 51 to 52v46
  23. Study sites: 50 to 51v45
  24. Study sites: 49 to 50v44
  25. Study sites: 48 to 49v43
  26. Study sites: 47 to 48v42
  27. Study sites: 46 to 47v41
  28. Study sites: 43 to 46v40
  29. Study sites: 42 to 43v39
  30. Study sites: 41 to 42v38
  31. Study sites: 40 to 41v37
  32. Study sites: 39 to 40v36
  33. Site details revised at 1 of 39 sitesv35
  34. Site details revised at 1 of 39 sitesv34
  35. Study sites: 37 to 39v33
  36. Study sites: 36 to 37v32
  37. Study sites: 35 to 36v31
  38. Study sites: 34 to 35v30
  39. Study sites: 33 to 34v29
  40. Study sites: 32 to 33v28
  41. Site contacts updated at 1 of 32 sitesv27
  42. Study sites: 31 to 32v26
  43. Site details revised at 1 of 31 sitesv25
  44. Study sites: 29 to 31v24
  45. Study sites: 28 to 29v23
  • 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.
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45%
Trial Details
NCT Number NCT03970343
Lead Sponsor Impulse Dynamics
Conditions Heart Failure
Enrollment 620 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov