Status:

COMPLETED

Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder

Lead Sponsor:

National and Kapodistrian University of Athens

Conditions:

Foramen Ovale, Patent

Nickel Sensitivity

Eligibility:

All Genders

14+ years

Phase:

NA

Brief Summary

Percutaneous PFO closure has been established as a first-line therapy for preventing recurrent strokes in selected patients. The devices used for the specific purpose contain and release nickel, which...

Detailed Description

Percutaneous PFO closure has been established as a first-line therapy for preventing recurrent strokes, after embolic stroke of unknown source (ESUS) and a patent foramen ovale. The PFO closure is ach...

Eligibility Criteria

Inclusion

  • Age: at least 14 years old
  • Well-documented indication for percutaneous PFO closure

Exclusion

  • Corticosteroid treatment
  • Patient's refusal to participation

Key Trial Info

Start Date :

December 10 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2024

Estimated Enrollment :

96 Patients enrolled

Trial Details

Trial ID

NCT04713683

Start Date

December 10 2020

End Date

December 1 2024

Last Update

February 6 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

First Department of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital of Athens

Athens, Attica, Greece, 115 28