New device offers hope for heart defect patients with failing circulation

NCT ID NCT07532369

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at a device called the Occlutech Atrial Flow Regulator (AFR) in 25 people whose Fontan circulation (a surgery for a heart defect) is failing. The goal is to see if the device is safe and works well to create a small hole between heart chambers to improve blood flow. Participants have already received the device through a special FDA program.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities univentricular heart

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

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

  • Contact

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

Locations

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

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

    Contact

    Contact

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

    Contact

    Contact

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

  • Cook Children's Health Care System

    Fort Worth, Texas, 76104, United States

    Contact

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

  • Duke University

    Durham, North Carolina, 27705, United States

    Contact

    Contact

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

    Contact

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

    Peoria, Illinois, 61637, United States

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

    Contact

  • Rady Children's San Deigo

    San Diego, California, 92123, United States

    Contact

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

  • University of Alabama

    Birmingham, Alabama, 35233, United States

    Contact Email: •••••@•••••

    Contact