New device aims to seal heart hole and prevent second strokes
NCT ID NCT07380490
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study compares two medical devices used to close a small hole in the heart called a PFO, which can cause strokes. About 1,260 adults who have had a stroke or mini-stroke in the past year will be randomly assigned to receive either the Cocoon PFO Occluder or the Amplatzer PFO Occluder. The main goal is to see if the Cocoon device is as safe and effective as the Amplatzer at preventing another stroke, mini-stroke, or death within 12 months.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Cocoon PFO Occluder (device) versus Amplatzer PFO Occluder (device)
What this could lead to
If successful, this could show that the Cocoon device is a safe and effective alternative to the Amplatzer device for closing a hole in the heart to prevent future strokes.
What could go wrong
This is a non-inferiority trial, meaning it aims to show the Cocoon device is not worse than the Amplatzer, not necessarily better. The results may not apply to all patients, and device-related risks like blood clots or device migration are possible.
Disclaimer
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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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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.
Contacts and locations
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Study contacts
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