Stitch vs plug: new heart hole closure device tested to stop strokes
NCT ID NCT04339699
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.
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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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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Contact
Phone: •••-•••-•••• Email: •••••@•••••
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Ospedale S. Eugenio
RECRUITINGRome, Lazio, 00144, Italy
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact Phone: •••-•••-•••• Email: •••••@•••••
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TMC HealthCare
RECRUITINGTucson, Arizona, 85712, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact