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SUSPENDED
NCT04902053

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

Sponsor: Edwards Lifesciences

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2028-06

Completion Date

2031-01

Last Updated

2026-08-04

Healthy Volunteers

No

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.

Locations (7)

University of Southern California

Los Angeles, California, United States

University of Florida

Gainesville, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

St. Vincent Hospital

Indianapolis, Indiana, United States

Nyph/Cumc

New York, New York, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States