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PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

Study acronym: PROGRESS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 1 of 80 sitesv40
  2. Secondary endpoints: 10 to 5v39 See this version in full on ClinicalTrials.gov ↗
  3. Site details revised at 2 of 80 sitesv38
  4. Site details revised at 3 of 80 sitesv37
  5. Study sites revised (80)v36 See this version in full on ClinicalTrials.gov ↗
Show 34 earlier versionsHide 34 earlier versions
  1. Site details revised at 1 of 80 sitesv35
  2. Site details revised at 4 of 80 sitesv34
  3. Site details revised at 5 of 80 sitesv33
  4. Site details revised at 5 of 80 sitesv32
  5. Site details revised at 10 of 80 sitesv31
  6. Site details revised at 7 of 80 sitesv30
  7. Site details revised at 10 of 80 sitesv29
  8. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 1294 to 2250 · Study sites: 75 to 80v28 Show 2 more changesShow less
    • Enrollment target: 1294 to 2250
    • Study sites: 75 to 80
  9. Study sites: 76 to 75v27
  10. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 750 to confirmed 1294 · Study sites: 80 to 76v26 Show 2 more changesShow less
    • Enrollment target: estimated 750 to confirmed 1294
    • Study sites: 80 to 76
  11. Study sites: 77 to 80v25
  12. Study sites: 75 to 77v24
  13. Study sites: 74 to 75v23
  14. Primary endpoints: 1 to 2 Study sites: 72 to 74 · Interventions: SAPIEN 3 / SAPIEN 3 Ultra (Device) to SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA (Device) · Secondary endpoints: 9 to 10 · 2 morev22 Show 5 more changesShow less
    • Study sites: 72 to 74
    • Interventions: SAPIEN 3 / SAPIEN 3 Ultra (Device) to SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA (Device)
    • Secondary endpoints: 9 to 10
    • Study description expanded, about 6 words
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 71 to 72v21
  16. Study sites: 68 to 71v20
  17. Site details revised at 1 of 68 sitesv19
  18. Study sites: 65 to 68v18
  19. Study sites: 62 to 65v17
  20. Study sites: 58 to 62v16
  21. Study sites: 53 to 58v15
  22. Study sites: 47 to 53v14
  23. Study sites: 42 to 47v13
  24. Study sites: 39 to 42v12
  25. Study sites: 35 to 39v11
  26. Study sites: 30 to 35v10
  27. Study sites: 26 to 30v9
  28. Study sites: 19 to 26v8
  29. Study sites: 14 to 19v7
  30. Study sites: 8 to 14v6
  31. Study sites: 6 to 8v5
  32. Study sites: 3 to 6v4
  33. Primary endpoint revised Study sites: 1 to 3 · Start date changed from estimate of Dec 2021 to Oct 12, 2021 · Secondary endpoints expanded, about 56 wordsv3 Show 3 more changesShow less
    • Study sites: 1 to 3
    • Start date changed from estimate of Dec 2021 to Oct 12, 2021
    • Secondary endpoints expanded, about 56 words

    See this version in full on ClinicalTrials.gov ↗

  34. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  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.
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Trial Details
NCT Number NCT04889872
Lead Sponsor Edwards Lifesciences
Conditions Aortic Stenosis, Calcific, Aortic Valve Stenosis
Enrollment 2,250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov