PFx Closure System in Subjects With Cryptogenic Stroke, TIA, Migraine or Decompression Illness "Paradigm IV"

Suspended

Phase N/A Results N/A

Trial Description

The primary object of this study is to demonstrate the continued safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.

Conditions

Interventions

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary PFO closure at 6 months post procedure. 6 months post procedure Yes
Secondary PFO closure at 30 days and 12 months post procedure. AE event rate for all subjects. Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine. 30 days; 6 and 12 months Yes

Sponsors