clinical trial · NCT04902053
INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study
Edwards Lifesciences·—·suspended·n = 50
Aortic Valve ReplacementSubjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment.
brief summary
The primary objective of the INSPIRIS RESILIA Aortic Valve-in-valve (ViV) Surveillance Study ("the Study") is to capture Adverse Event information and valve measurement data from dysfunctional INSPIRIS RESILIA aortic valves before and after Valve-in-valve (ViV) treatment.
started
Jun 1, 2028
primary completion
Dec 1, 2030
completion
Jan 1, 2031
last updated
Sep 2, 2025
detailed description
This is a single-arm observational study which includes both prospective and retrospective data.
At least fifty (50) Subjects enrolled prospectively prior to the ViV procedure, or retrospectively after the ViV procedure (within 37 days post-ViV procedure) with dysfunctional 19mm-25mm INSPIRIS aortic valves, will participate in this study.
All subjects will be followed for up to 1 month after the TAVR ViV procedure.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol