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ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 31 → 34 locations
  2. Study sites: 29 to 31
    • Eligibility criteria expanded, about 60 words
    • Secondary endpoints: details revised at 3 of 20 entries
  3. Primary completion pushed from Jun 2026 to Jun 2027
    • Study sites: 28 to 29
    v13
  4. Study sites: 27 to 28v12
  5. Trial sites expanded: 24 → 27 locationsv11
  6. Trial sites expanded: 21 → 24 locationsv10
  7. Study sites: 20 to 21v9
  8. Study sites: 19 to 20v8
  9. Study sites: 17 to 19v7
  10. Study sites: 13 to 17v6
  11. Study sites: 9 to 13v5
  12. Study sites: 5 to 9v4
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 5
    • Primary completion date: Feb 2026 to Jun 2026
    • Start date changed from estimate of Mar 2025 to Jun 18, 2025
    v3
  14. Study sites: 0 to 2
    • Start date: Jan 2025 to Mar 2025
    v2
  15. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)
Trial Details
NCT Number NCT06608823
Lead Sponsor JenaValve Technology, Inc.
Conditions
(from sponsor)		 Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
Related terms Aortic Valve Insufficiency
Enrollment 1,016 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov