New heart device tested in everyday use to seal birth defects

NCT ID NCT05887700

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking 145 people who have a hole in their heart (atrial septal defect) and received the CeraFlex closure device. Researchers want to see how well the device works in real-world settings, focusing on safety and successful closure of the hole at 6 months. The device is implanted through a tube in a blood vessel, avoiding open-heart surgery.

What this could mean

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

Active substance

CeraFlex ASD closure device (a heart implant that closes a hole in the heart wall)

What this could lead to

If successful, this registry could confirm that the CeraFlex device is a safe and effective option for closing atrial septal defects without open-heart surgery.

What could go wrong

This is an observational registry, not a controlled trial, so results may be less definitive. Risks include device-related complications like stroke, embolization, or residual shunts.

Disclaimer Read more

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.

atrial septal defect

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: •••••@•••••

Locations

  • HCOR - Associação Beneficente Síria

    RECRUITING

    São Paulo, Brazil

    Contact

  • Hospital Beneficência Portuguesa

    RECRUITING

    São Paulo, Brazil

    Contact

  • Hospital Pequeno Príncipe

    RECRUITING

    Curitiba, Brazil

    Contact

  • Onassis Cardiac Surgery Center

    RECRUITING

    Kallithea, Greece

    Contact

    Contact

  • Santa Casa de Misericórdia de Porto Alegre

    RECRUITING

    Porto Alegre, Brazil

    Contact