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INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study — INVIVITY  

Aortic Valve Replacement Clinical Trial

Official title:
INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04902053
Study type Observational
Source Edwards Lifesciences
Contact
Status Suspended
Phase
Start date June 2028
Completion date January 2031
View Details
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