NCT00196027

Paradigm I Clinical Trial: Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemia Attack or Paradoxical Embolism

Feasibility Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemia Attack or Paradoxical Embolism

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Cierra · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to demonstrate the safety of the PFX Closure System when utilized for patients with patent foramen ovale (PFO) suffering from cryptogenic stroke, transient ischemic attacks or paradoxical embolism.

Detailed description

Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack (TIA), and right to left gas embolism in severe decompression illness. An association between patent foramen ovale and severe migraine headaches has also been reported. Several implantable devices are being used for percutaneous closure of patent foramen ovale; we propose to use a non-implantable system to safely effect closure.

Conditions

• Patent Foramen Ovale

Interventions

Type	Name	Description
DEVICE	PFX Closure System

Timeline

• Start date: 2005-04-01
• First posted: 2005-09-20
• Last updated: 2006-11-29

Locations

1 site across 1 country: Germany