Heart-Device study aims to stop strokes in patients with a hole in the heart

NCT ID NCT05529901

Ongoing Disease control Sponsor: W.L.Gore & Associates Source: ClinicalTrials.gov ↗

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

Summary

This study is checking how well a device called the GORE® CARDIOFORM Septal Occluder works and how safe it is for people who have had a stroke caused by a hole in the heart (PFO). Researchers will follow 300 patients in Japan for 12 months after the device is implanted. The goal is to see if the device closes the hole and helps prevent future strokes.

What this could mean

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

Active substance: GORE® CARDIOFORM Septal Occluder (a device implanted to close a hole in the heart)
What this could lead to: If successful, this could confirm that the device is a safe and effective way to prevent future strokes in people with a PFO.
What could go wrong: This is an observational study, not a randomized trial, so it cannot prove the device is better than other treatments. Results may not apply outside Japan.

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.

Ischemic Stroke patent foramen ovale stroke disorder transient ischemic attack

As listed by the trial registrant

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

CRYPTOGENIC STROKE PFO - PATENT FORAMEN OVALE STROKE TIA

Contacts and locations

Locations

Okayama University Hospital

Okayama, 700-8558, Japan

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