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

SuspendedOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

June 30, 2028

Primary Completion Date

December 31, 2030

Study Completion Date

January 31, 2031

Conditions
Aortic Valve Replacement
Interventions
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.

Trial Locations (7)

10032

Nyph/Cumc, New York

19104

University of Pennsylvania, Philadelphia

32611

University of Florida, Gainesville

32803

AdventHealth Orlando, Orlando

44195

The Cleveland Clinic Foundation, Cleveland

46290

St. Vincent Hospital, Indianapolis

90033

University of Southern California, Los Angeles

Sponsors
All Listed Sponsors
lead

Edwards Lifesciences

INDUSTRY