Stitch vs plug: new heart hole closure device tested to stop strokes

NCT ID NCT04339699

Recruiting now Disease control Sponsor: Nobles Medical Technologies II Inc Source: ClinicalTrials.gov ↗

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

Summary

This study tests a new device that uses stitches to close a small hole in the heart (called PFO) in people who have had a stroke. It compares the stitch method to a standard metal plug device. About 640 adults aged 18-60 with a PFO and a recent stroke will be enrolled. The goal is to see which method closes the hole better and prevents 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: NobleStitch EL suture-mediated closure system (a device that stitches the hole closed) compared to Amplatzer PFO Occluder (a metal implant that plugs the hole)
What this could lead to: If successful, this could offer a metal-free alternative for closing a common heart hole, potentially reducing the risk of future strokes without leaving a permanent implant.
What could go wrong: This is a mid-stage study with 640 people, so results are not final. The new stitch method may not close the hole as effectively as the standard device, or could have different risks like bleeding or incomplete closure.

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

As listed by the trial registrant

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

FORAMEN OVALE, PATENT STROKE, ISCHEMIC

Contacts and locations

Locations

Ospedale S. Eugenio
RECRUITING

Rome, Lazio, 00144, Italy
TMC HealthCare
RECRUITING

Tucson, Arizona, 85712, United States

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