Groundbreaking trial seeks First-Ever FDA approval for child Heart-Lung support device

NCT ID NCT06080074

Summary

This study aims to test the safety and effectiveness of a heart-lung support machine called the Cardiohelp System in children with life-threatening heart failure. It will also compare two different blood thinners used with the device. The goal is to gather enough evidence for the device to become the first of its kind officially approved by the FDA for use in children.

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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Contacts and locations

Study contacts

  • Contact

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

  • Contact

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

Locations

  • Children's Health Dallas

    RECRUITING

    Dallas, Texas, 95235, United States

    Contact Email: •••••@•••••

  • Cuimc/Nyph

    RECRUITING

    New York, New York, 10032, United States

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

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27710, United States

    Contact Email: •••••@•••••

  • Lucile Packard Children's Hospital

    RECRUITING

    Palo Alto, California, 94304, United States

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

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

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

Conditions

Explore the condition pages connected to this study.