New device aims to seal heart hole and prevent second strokes

NCT ID NCT07380490

Not yet recruiting Disease control Sponsor: Giuseppe Tarantini Source: ClinicalTrials.gov ↗

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.

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.

PATENT FORAMEN OVALE STROKE TRANSIENT ISCHEMIC ATTACK (TIA)

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