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SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

Study acronym: SMART
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Feb 12, 2026, no change to tracked fieldsv39-v40
  2. Secondary endpoints: details revised at 1 of 5 entriesv38
  3. 3 versions Re-verified since Apr 1, 2025, no change to tracked fieldsv35-v37
  4. Results first posted: Mar 20, 2025v34
  5. Secondary endpoints: details revised at 2 of 5 entriesv33
Show 31 earlier versionsHide 31 earlier versions
  1. Enrollment target: 716 to 1103
    • Secondary endpoints revised (5)
    • Primary endpoints revised (2)
    v32
  2. 4 versions Re-verified since Mar 22, 2024, no change to tracked fieldsv28-v31
  3. Primary completion date changed from estimate of Nov 2023 to Nov 10, 2023v27
  4. 7 versions Re-verified since Dec 8, 2022, no change to tracked fieldsv20-v26
  5. Trial status: Recruiting to Active, Not Recruitingv19 Show 4 more changesShow less
    • Enrollment target: estimated 700 to confirmed 716
    • Study sites: 91 to 92
    • Primary completion date: Dec 2023 to Nov 2023
    • Study completion date: Jan 2028 to Dec 2027
  6. Interventions: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems (Device), Medtronic Evolut PRO or Evolut PRO+ TAV Systems (Device) to Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems (Device), Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV…
    • Eligibility criteria revised
    • Study description expanded, about 18 words
    • Site contacts updated at 2 of 91 sites
    v18
  7. Study sites: 76 to 91v17
  8. Study sites: 75 to 76v16
  9. Study description expanded, about 38 wordsv15
  10. Study sites: 70 to 75v14
  11. Study sites: 61 to 70v13
  12. Primary completion date: May 2023 to Dec 2023v12 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Study sites: 59 to 61
    • Study completion date: May 2028 to Jan 2028
    • Eligibility criteria expanded, about 18 words
  13. Study sites: 51 to 59v11
  14. Study sites: 37 to 51v10
  15. Study sites: 30 to 37v9
  16. Study sites: 25 to 30v8
  17. Study sites: 17 to 25v7
  18. Study sites: 13 to 17v6
  19. Study sites: 4 to 13v5
  20. Study sites: 1 to 4v4
  21. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2021 to Apr 2, 2021
    v3
  22. Start date: Feb 2021 to Mar 2021v2
  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 purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. Additionally, a stress echocardiography sub-study will be conducted as part of the SMART Trial at select sites. The purpose of the sub-study is to evaluate performance of SE versus BE TAVR in subjects with a small aortic annulus and symptomatic severe native aortic stenosis after undergoing exercise stress echocardiographic testing.
Trial Details
NCT Number NCT04722250
Lead Sponsor Medtronic Cardiovascular
Conditions
(from sponsor)		 Symptomatic Aortic Stenosis, Aortic Valve Stenosis, Aortic Valve Replacement
Related terms Aortic Valve Stenosis
Enrollment 1,103 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov