New device aims to seal heart holes and prevent strokes

NCT ID NCT06120270

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study follows 180 people who receive the CeraFlex PFO Closure System, a device that closes a small hole in the heart called a patent foramen ovale (PFO). The goal is to see how well the device works in everyday medical practice, especially for patients with migraines or strokes linked to PFO. Researchers will track procedure success and any leftover shunts after the device is placed.

What this could mean

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

Active substance

CeraFlex PFO Closure System (a device implanted to close a hole in the heart)

What this could lead to

If successful, this could confirm that the CeraFlex device safely and effectively closes PFO, reducing the risk of stroke and migraine in patients.

What could go wrong

This is an observational study, not a controlled trial, so results may not prove the device is better than other treatments. Risks include device complications or incomplete closure.

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.

patent foramen ovale

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

  • ASAN Medical Center

    RECRUITING

    Seoul, South Korea

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

  • Catholic University of Korea St. Vincent's Hospital

    RECRUITING

    Suwon, South Korea

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

  • Chonnam National University Hospital

    RECRUITING

    Gwangju, Gwangju, 57393, South Korea

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

  • German Heart Center Leipzig

    RECRUITING

    Leipzig, Germany

    Contact

  • German Heart Center Munich

    RECRUITING

    Munich, Germany

    Contact

  • Heart Center Dresden

    NOT_YET_RECRUITING

    Dresden, Germany

    Contact

  • Herzzentrum Trier

    RECRUITING

    Trier, Germany

    Contact

  • Hospital Fürth

    RECRUITING

    Fürth, Germany

    Contact

  • Kardiologisch-Angiologische Praxis - Herzzentrum Bremen

    RECRUITING

    Bremen, Germany

    Contact

  • Kath. Marienkrankenhaus gGmbH

    RECRUITING

    Hamburg, Germany

    Contact

  • Klinikum St. Georg gGmbH Leipzig

    NOT_YET_RECRUITING

    Leipzig, Germany

    Contact

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

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

  • University clinic Tübingen

    RECRUITING

    Tübingen, Germany

    Contact

  • Universitätsklinikum Hamburg-Eppendorf (UKE)

    RECRUITING

    Hamburg, Germany

    Contact

  • Yeungnam University Medical Center

    RECRUITING

    Daegu, South Korea

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