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NCT05536310 · ClinicalTrials.gov record · last posted 2026-08-21

TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease

Study acronym: TAVIS
StatusTerminated
PhaseNot specified
Started2023-08-01
View on ClinicalTrials.gov ↗
Why the trial stopped
Inadequate study design which restricted study enrollment suitable for a registry.
from the ClinicalTrials.gov record
To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).

Protocol amendment history 5 changes detected by DataLookout

2026-08-22
Trial status changed: Not Yet Recruiting → Terminated
2026-08-22
Trial terminated: Inadequate study design which restricted study enrollment suitable for a registry.
2026-08-22
Enrollment reduced: 600 → 24 participants
2026-08-22
Primary completion pushed: 2023-10 → 2024-07-09
2026-08-22
Completion moved earlier: 2027-10 → 2024-07-09
Trial Details
NCT Number NCT05536310
Lead Sponsor JenaValve Technology, Inc.
Conditions Aortic Valve Stenosis, Aortic Valve Regurgitation, Aortic Valve Stenosis With Insufficiency, Constriction, Pathologic, Aortic Valve Disease, Heart Valve Diseases, Cardiovascular Diseases in Old Age, Ventricular Outflow Obstruction +1 more
Enrollment 24 participants
Start Date 2023-08-01
Primary Completion 2024-07-09 (estimated)
Study Completion 2024-07-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-21