Heart-Device study aims to stop strokes in patients with a hole in the heart
NCT ID NCT05529901
First seen Nov 20, 2025 · Last updated Jun 20, 2026 · Updated 28 times
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.
Disclaimer
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This is a summary of
the original study
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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.
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
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Locations
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Okayama University Hospital
Okayama, 700-8558, Japan
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.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.