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Evolut™ EXPAND TAVR II Pivotal Trial

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria expanded, about 7 words
    • Site details revised at 7 of 94 sites
  2. Site details revised at 6 of 94 sitesv43
  3. Primary completion date: Feb 2026 to Sep 2027
    • Study sites: 93 to 94
    v42
  4. Study sites: 97 to 93v41
  5. Re-verified, no change to tracked fieldsv40
Show 38 earlier versionsHide 38 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 99 to 97
    v39
  2. Re-verified, no change to tracked fieldsv38
  3. Study sites revised (99)v37
  4. 2 versions Re-verified since Feb 12, 2025, no change to tracked fieldsv35-v36
  5. Study sites: 100 to 99v34
  6. Study sites revised (100)v33
  7. Study sites revised (100)v32
  8. Study sites: 99 to 100v31
  9. Re-verified, no change to tracked fieldsv30
  10. Study sites: 98 to 99v29
  11. Eligibility criteria shortened, about 8 wordsv28
  12. Study sites revised (98)v27
  13. Study sites: 93 to 98v26
  14. Study sites: 89 to 93v25
  15. Study sites: 85 to 89v24
  16. Study sites revised (85)
    • Eligibility criteria expanded, about 1 word
    v23
  17. Study sites: 83 to 85
    • Eligibility criteria expanded, about 55 words
    v22
  18. Study sites: 80 to 83
    • Eligibility criteria expanded, about 25 words
    v21
  19. Study sites: 77 to 80v20
  20. Study sites: 74 to 77v19
  21. Study sites: 66 to 74v18
  22. Study sites: 55 to 66v17
  23. Study sites: 48 to 55v16
  24. Study sites: 39 to 48v15
  25. Study sites: 33 to 39v14
  26. Study sites: 28 to 33v13
  27. Primary endpoints revised (2)v12
  28. Primary endpoints revised (2)v11 Show 4 more changesShow less
    • Study sites: 27 to 28
    • Interventions: Medtronic Evolut PRO+ TAVR System and guideline-directed management and therapy (GDMT) (Device) to Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT) (Device)
    • Secondary endpoints revised (7)
    • Study description expanded, about 4 words
  29. Study sites: 24 to 27v10
  30. Study sites: 15 to 24v9
  31. Study sites: 7 to 15v8
  32. Study sites: 5 to 7v7
  33. Primary endpoints revised (2)
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (7)
    v6
  34. Study sites: 1 to 5v5
  35. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2022 to Apr 27, 2022
    v4
  36. Start date: Mar 2022 to Apr 2022v3
  37. Start date: Jan 2022 to Mar 2022v2
  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.
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
Trial Details
NCT Number NCT05149755
Lead Sponsor Medtronic Cardiovascular
Conditions
(from sponsor)		 Moderate Aortic Valve Stenosis
Related terms Constriction, Pathologic, Lymphoma, Follicular
Enrollment 650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov