Clinical Trial

Real World Data Collection on the INSPIRIS RESILIA Aortic Valve

Study acronym: INDICATE
Recruiting
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Summary
Collect real-world data on hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A, in subjects requiring replacement of their native or prosthetic aortic valve as the only heart valve procedure during the index procedure, with or without other concomitant procedures.
Protocol Amendment History 2 changes
notable Trial sites expanded: 11 -> 14 locations 2026-06-23
notable Trial sites expanded: 8 -> 11 locations 2026-04-03
Trial Details
NCT Number NCT07120048
Lead Sponsor Edwards Lifesciences
Conditions Aortic Valve Disease
Enrollment 500 participants
Start Date 2025-07-30
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-22