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NCT06608823 · ClinicalTrials.gov record · last posted 2026-07-07

ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™

Study acronym: ARTIST
StatusRecruiting
PhaseNot applicable
Started2025-06-18
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from the ClinicalTrials.gov record
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)

Protocol amendment history 3 changes detected by DataLookout

2026-07-08
Primary completion pushed: 2026-06 → 2027-06
2026-06-10
Trial sites expanded: 24 → 27 locations
2026-05-20
Trial sites expanded: 21 → 24 locations
Trial Details
NCT Number NCT06608823
Lead Sponsor JenaValve Technology, Inc.
Conditions Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
Enrollment 1,016 participants
Start Date 2025-06-18
Primary Completion 2027-06 (estimated)
Study Completion 2036-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-07