New heart device aims to seal Stroke-Causing hole

NCT ID NCT07698951

Recruiting now Disease control Sponsor: Recross Cardio, Inc. Source: ClinicalTrials.gov ↗

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This trial tests a new device called the P3 Occluder System designed to close a patent foramen ovale (PFO) — a small opening between the upper chambers of the heart. The study includes adults aged 18 to 65 who have had a stroke possibly linked to a PFO. Participants receive the implant and are followed for up to three years to see if the device safely and effectively closes the opening and reduces the risk of another stroke.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Recross P3 Occluder (P3O) System
What this could lead to: If successful, this device could offer a safe and effective way to close a PFO and reduce the risk of recurrent stroke in affected patients.
What could go wrong: This is a small, early-stage study with only 15 participants, so results may not apply to everyone. There are risks from the implant procedure, including serious adverse events like stroke or heart issues.

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.

CRYPTOGENIC STROKE PATENT FORAMEN OVALE PFO PFO - PATENT FORAMEN OVALE PFO-ASSOCIATED STROKE

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Institute for cardiovascular diseases ''Dedinje'', Belgrade
RECRUITING

Belgrade, Serbia

Contact Email: •••••@•••••

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