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PFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00335296
Recruitment Status : Suspended
First Posted : June 9, 2006
Last Update Posted : December 24, 2007
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Brief Summary:
The primary objective of this study is to demonstrate the 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.

Condition or disease Intervention/treatment Phase
Patent Foramen Ovale Device: PFx catheter Not Applicable

Detailed Description:
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; this study uses a non-implantable system to safely effect closure with the application of radiofrequency energy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Paradigm IIca/III Trial: PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
Study Start Date : May 2006
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. PFO closure 6 months post procedure [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. PFO closure at 30 days and 12 months post procedure [ Time Frame: 30 days, 12 months ]
  2. AE event rates for all subjects [ Time Frame: 30 days, 6 and 12 months ]
  3. Migraine severity [ Time Frame: 6 and 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age between 18 and 65 years old
  • Documented PFO
  • Subjects with one or more of the following:cryptogenic stroke, transient ischemic attack, embolism, migraine headaches, decompression illness

Exclusion Criteria:

• Inappropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00335296

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AZ Middleheim Hospital
Antwerpen, Belgium
Institut Hospitalier Jacques Carter
Massy, France
Bichat Hospital
Paris, France, 75877
Cardiovascular Center Frankfurt Sankt katharinen
Frankfurt, Germany, 60389
Sponsors and Collaborators
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Principal Investigator: Alec Vahanian, MD Bichat Hospital
Layout table for additonal information Identifier: NCT00335296    
Other Study ID Numbers: CA0005/09
First Posted: June 9, 2006    Key Record Dates
Last Update Posted: December 24, 2007
Last Verified: December 2007
Keywords provided by Cierra:
TIA (transient ischemic attack)
Decompression Illness
Additional relevant MeSH terms:
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Migraine Disorders
Ischemic Attack, Transient
Foramen Ovale, Patent
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Headache Disorders, Primary
Headache Disorders
Brain Ischemia
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities