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

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Conditions studied: Aortic Valve Replacement

In brief

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 facts

Study ID

NCT04902053

Run by

Edwards Lifesciences

People needed

50

Starts

2028-06-01

Expected to finish

2031-01-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following Inclusion Criteria:
• 18 years or older at the time of the TAVR ViV treatment
• Has an INSPIRIS RESILIA aortic valve implanted in the aortic position confirmed to be size 19mm, 21mm, 23mm or 25mm
• A ViV procedure using an Edwards transcatheter aortic heart valve (TAVR) has been scheduled; or completed within 37 days from time of consent
• The participant agrees to attend a follow-up assessment at 1 month post ViV procedure
• The participant provides written informed consent prior to the post-ViV procedure CT scan

You may not qualify if…

• Subjects must not meet any of the following Exclusion Criteria:
• The INSPIRIS RESILIA aortic valve size is
• Unconfirmed, or
• Confirmed to be 27mm or 29mm
• Prior re-interventions have been performed on the INSPIRIS RESILIA aortic valve
• The INSPIRIS RESILIA aortic valve has been subjected to balloon aortic valvuloplasty (BAV) prior to the baseline quantitative area measurement of the valve area
• The Subject is pregnant or desires to become pregnant within 40 days of the ViV procedure
• Subjects with a known contraindication or hypersensitivity to contrast media that cannot be adequately pre-medicated per hospital guidelines

Where it is running

• 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

Full record on ClinicalTrials.gov

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