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Suspended study tracks Valve-in-Valve outcomes for aortic valve patients

NCT ID NCT04902053

Terminated Knowledge-focused Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study follows 50 people who previously received an INSPIRIS RESILIA aortic valve and now need a valve-in-valve procedure because their original valve is not working well. Researchers will track complications like death, stroke, bleeding, and valve movement, as well as how well the new valve expands. The goal is to gather safety and performance data, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Edwards transcatheter aortic valve (TAVR) used in valve-in-valve procedure
What this could lead to
If successful, this study could provide data to improve safety and effectiveness of valve-in-valve treatments for patients with failing INSPIRIS RESILIA aortic valves.
What could go wrong
This is a small, observational study (50 participants) that is currently suspended. It does not test a new treatment but gathers information, so no direct benefit to participants is guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

aortic valve disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AORTIC VALVE REPLACEMENT

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Nyph/Cumc

    New York, New York, 10032, United States

  • St. Vincent Hospital

    Indianapolis, Indiana, 46290, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • University of Florida

    Gainesville, Florida, 32611, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

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