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Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv37
  2. Study completion date: Mar 2026 to Jun 2029v36
  3. Re-verified, no change to tracked fieldsv35
  4. Study sites revised (87)v34
  5. 3 versions Re-verified since Apr 30, 2024, no change to tracked fieldsv31-v33
Show 29 earlier versionsHide 29 earlier versions
  1. Site details revised at 1 of 87 sitesv30
  2. Re-verified, no change to tracked fieldsv29
  3. Study sites revised (87)v28
  4. Site details revised at 3 of 87 sitesv27
  5. Study sites: 88 to 87v26
  6. Enrollment target: 1478 to 2223
    • Primary endpoint revised
    • Secondary endpoints revised (10)
    v25
  7. Study sites revised (88)v24
  8. Re-verified, no change to tracked fieldsv23
  9. Results first posted: Sep 9, 2021
    • Primary endpoint revised
    • Enrollment target: 1411 to 1478
    • Secondary endpoints revised (10)
    v22
  10. Study sites revised (88)v21
  11. Study sites: 89 to 88v20
  12. 3 versions Re-verified since Oct 28, 2019, no change to tracked fieldsv17-v19
  13. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1200 to confirmed 1411
    • Study sites: 90 to 89
    v16
  14. Site details revised at 2 of 90 sitesv15
  15. Site details revised at 30 of 90 sitesv14
  16. Site details revised at 27 of 90 sitesv13
  17. Study sites: 81 to 90
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 1 of 10 entries
    • Study description expanded, about 56 words
    v12
  18. Primary completion date: Mar 2026 to Apr 2021v11
  19. Study title expanded, about 1 wordv10
  20. Primary completion date: Mar 2018 to Mar 2026
    • Study sites: 74 to 81
    v9
  21. Re-verified, no change to tracked fieldsv8
  22. Study sites: 58 to 74
    • Eligibility criteria shortened, about 13 words
    v7
  23. Re-verified, no change to tracked fieldsv6
  24. Enrollment target: 1250 to 1200v5 Show 4 more changesShow less
    • Study sites: 48 to 58
    • Study completion date: Mar 2023 to Mar 2026
    • Eligibility criteria expanded, about 128 words
    • Study description revised
  25. Study sites: 1 to 48v4
  26. Re-verified, no change to tracked fieldsv3
  27. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  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.
The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.
Trial Details
NCT Number NCT02701283
Lead Sponsor Medtronic Cardiovascular
Conditions
(from sponsor)		 Aortic Valve Stenosis
Related terms Aortic Valve Stenosis
Enrollment 2,223 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov