Clinical Trial: The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Feasibility Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

Brief Summary: The primary objective of this study is to demonstrate the safety and efficacy of the PFX Closure System when utilized for patent foramen ovale (PFO) in patients suffering from cryptogenic stroke (undetermined cause of stroke), transient ischemic attack (brief neurological dysfunction), migraine or decompression illness.

Detailed Summary: Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack, 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.
Sponsor: Cierra

Current Primary Outcome: PFO closure as measured by transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) acutely post procedure

Original Primary Outcome: PFO closure as measured by TEE or ICE acutely post procedure

Current Secondary Outcome:

  • PFO closure as measured by TEE or transthoracic echocardiography (TTE) at 30 days, 3 or 6 months and 12 months post procedure
  • Adverse event (AE) rates for all subjects
  • New conduction abnormality rate through final follow-up
  • Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine


Original Secondary Outcome:

  • PFO closure as measured by TEE or TTE at 30 days, 3 or 6 months and 12 months post procedure.
  • AE event rates for all subjects
  • New conduction abnormality rate through final follow-up
  • Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine.


Information By: Cierra

Dates:
Date Received: September 12, 2005
Date Started: October 2005
Date Completion:
Last Updated: December 18, 2007
Last Verified: December 2007