Heart hole showdown: new device vs. standard in stroke prevention trial

NCT ID NCT07380490

First seen Feb 02, 2026 · Last updated May 15, 2026 · Updated 15 times

Summary

This study tests if a new device (Cocoon PFO Occluder) is as safe and effective as the standard device (Amplatzer) for closing a small hole in the heart called a PFO. The hole can let blood clots travel to the brain, causing strokes. About 1,260 adults who had a stroke or mini-stroke in the past year will be randomly assigned to get one of the two devices. The main goal is to see if the new device is no worse at preventing another stroke, mini-stroke, or death within 12 months.

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