NCT04902053

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

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Aortic Valve Replacement

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment.	Designed to capture Adverse Event information and valve measurement data from dysfunctional INSPIRIS RESILIA aortic valves before and after Valve-in-valve (ViV) treatment.

Timeline

• Start date: 2028-06-01
• Primary completion: 2030-12-01
• Completion: 2031-01-01
• First posted: 2021-05-26
• Last updated: 2025-09-02

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study