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

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00335296
First Posted: June 9, 2006
Last Update Posted: December 24, 2007
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.
Information provided by:
Cierra
  Purpose
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 Intervention
Patent Foramen Ovale Device: PFx catheter

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Cierra:

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

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

Estimated Enrollment: 100
Study Start Date: May 2006
Estimated Study Completion Date: December 2007
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.
  Eligibility

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.


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

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.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00335296


Locations
Belgium
AZ Middleheim Hospital
Antwerpen, Belgium
France
Institut Hospitalier Jacques Carter
Massy, France
Bichat Hospital
Paris, France, 75877
Germany
Cardiovascular Center Frankfurt Sankt katharinen
Frankfurt, Germany, 60389
Sponsors and Collaborators
Cierra
Investigators
Principal Investigator: Alec Vahanian, MD Bichat Hospital
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00335296     History of Changes
Other Study ID Numbers: CA0005/09
First Submitted: June 8, 2006
First Posted: June 9, 2006
Last Update Posted: December 24, 2007
Last Verified: December 2007

Keywords provided by Cierra:
PFO
Migraine
Stroke
TIA (transient ischemic attack)
Decompression Illness

Additional relevant MeSH terms:
Ischemic Attack, Transient
Brain Ischemia
Migraine Disorders
Foramen Ovale, Patent
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities