New stitch device aims to outdo standard plug for stroke prevention

NCT ID NCT04339699

First seen Apr 05, 2026 · Last updated May 14, 2026 · Updated 8 times

Summary

This study tests a new stitch-based device (NobleStitch EL) against an approved plug device (Amplatzer) to close a small hole in the heart called PFO. The goal is to prevent a second stroke in 640 people aged 18-60 who have already had a stroke from an unknown cause. Participants will be followed for up to 5 years to see which device works better and is safer.

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Contacts and locations

Study contacts

  • Contact

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

  • Contact

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

Locations

  • Ospedale S. Eugenio

    RECRUITING

    Rome, Lazio, 00144, Italy

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

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

  • TMC HealthCare

    RECRUITING

    Tucson, Arizona, 85712, United States

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

    Contact

Conditions

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