New device offers hope for heart patients with failing fontan

NCT ID NCT07532369

First seen Apr 18, 2026 · Last updated May 12, 2026 · Updated 3 times

Summary

This study looks at a device called the Occlutech Atrial Flow Regulator (AFR) in people whose Fontan circulation is failing. The Fontan procedure is a surgery for people born with one working heart chamber. When it fails, patients can become very ill. The AFR is a small implant that creates a controlled hole between heart chambers to improve blood flow. The study will follow 25 patients for one year to see if the device stays open and is safe.

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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

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  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

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    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Cook Children's Health Care System

    Fort Worth, Texas, 76104, United States

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  • Duke University

    Durham, North Carolina, 27705, United States

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  • OSF Healthcare System d/b/a/ Saint Francis Medical Center

    Peoria, Illinois, 61637, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

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  • Rady Children's San Deigo

    San Diego, California, 92123, United States

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  • University of Alabama

    Birmingham, Alabama, 35233, United States

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Conditions

Explore the condition pages connected to this study.