New device aims to seal heart holes and prevent strokes

NCT ID NCT06120270

Recruiting now Disease control Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. Source: ClinicalTrials.gov ↗

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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.

PATENT FORAMEN OVALE

Contacts and locations

Locations

ASAN Medical Center
RECRUITING

Seoul, South Korea
Catholic University of Korea St. Vincent's Hospital
RECRUITING

Suwon, South Korea
Chonnam National University Hospital
RECRUITING

Gwangju, Gwangju, 57393, South Korea
German Heart Center Leipzig
RECRUITING

Leipzig, Germany
German Heart Center Munich
RECRUITING

Munich, Germany
Heart Center Dresden
NOT_YET_RECRUITING

Dresden, Germany
Herzzentrum Trier
RECRUITING

Trier, Germany
Hospital Fürth
RECRUITING

Fürth, Germany
Kardiologisch-Angiologische Praxis - Herzzentrum Bremen
RECRUITING

Bremen, Germany
Kath. Marienkrankenhaus gGmbH
RECRUITING

Hamburg, Germany
Klinikum St. Georg gGmbH Leipzig
NOT_YET_RECRUITING

Leipzig, Germany
Samsung Medical Center
RECRUITING

Seoul, South Korea
University clinic Tübingen
RECRUITING

Tübingen, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE)
RECRUITING

Hamburg, Germany
Yeungnam University Medical Center
RECRUITING

Daegu, South Korea

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