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Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

Study acronym: SURTAVI
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 79 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 6 versions Re-verified since Apr 30, 2024, no change to tracked fieldsv74-v79
  2. Study sites revised (86)v73
  3. 10 versions Re-verified since Apr 28, 2020, no change to tracked fieldsv63-v72
  4. Secondary endpoints: details revised at 1 of 25 entriesv62
  5. Results first posted: Sep 17, 2019v61 Show 4 more changesShow less
    • Primary endpoint revised
    • Enrollment target: estimated 2500 to confirmed 1746
    • Interventions: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI) (Device), Medtronic CoreValve® System Transcatheter… to Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI) (Device), Medtronic CoreValve® System Transcatheter…
    • Secondary endpoints: 23 to 25
Show 31 earlier versionsHide 31 earlier versions
  1. Re-verified, no change to tracked fieldsv60
  2. Eligibility criteria revised
    • Secondary endpoints revised (23)
    v59
  3. Re-verified, no change to tracked fieldsv58
  4. Primary completion date: Oct 2017 to Jul 2018
    • Study completion date: Oct 2018 to Nov 2026
    v57
  5. Study completion date: Oct 2017 to Oct 2018v56
  6. Re-verified, no change to tracked fieldsv55
  7. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 94 to 86
    v54
  8. Study completion date: Oct 2017
    • Site details revised at 6 of 94 sites
    v53
  9. Primary completion date: Oct 2016 to Oct 2017
    • Start date: Mar 2012 to Apr 2012
    • Site details revised at 33 of 94 sites
    v52
  10. Primary completion date: Aug 2016 to Oct 2016v51 Show 4 more changesShow less
    • Interventions: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI) (Device), Medtronic CoreValve® System Transcatheter… to Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI) (Device), Medtronic CoreValve® System Transcatheter…
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: 22 to 23
    • Site details revised at 55 of 94 sites
  11. Study sites: 93 to 94v50
  12. Study sites: 92 to 93v49
  13. Study sites: 83 to 92v48
  14. Site details revised at 1 of 83 sitesv47
  15. Study sites: 82 to 83
    • Interventions: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) (Device), Surgical Aortic Valve Replacement (SAVR) (Procedure) to Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI) (Device), Medtronic CoreValve® System Transcatheter…
    • Eligibility criteria expanded, about 183 words
    v46
  16. Study sites: 72 to 82
    • Eligibility criteria shortened, about 99 words
    • Secondary endpoints: details revised at 5 of 22 entries
    v45
  17. Re-verified, no change to tracked fieldsv44
  18. Study sites: 71 to 72v43
  19. Study sites: 51 to 71v42
  20. Study sites: 50 to 51v41
  21. Study sites: 49 to 50v40
  22. Study sites: 48 to 49v39
  23. Study sites: 47 to 48v38
  24. Site contacts updated at 2 of 47 sitesv37
  25. Study sites: 45 to 47v36
  26. Study sites: 44 to 45v35
  27. Study sites: 43 to 44v34
  28. Study sites: 42 to 43v33
  29. Study sites revised (42)v32
  30. Study sites: 41 to 42v31
  31. Study sites: 40 to 41v30
  • 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 purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.
Trial Details
NCT Number NCT01586910
Lead Sponsor Medtronic Cardiovascular
Conditions
(from sponsor)		 Severe Aortic Stenosis
Related terms Aortic Valve Stenosis
Enrollment 1,746 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov