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

This study has been suspended.
Sponsor:
Information provided by:
Cierra
ClinicalTrials.gov Identifier:
NCT00335296
First received: June 8, 2006
Last updated: December 18, 2007
Last verified: December 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00335296     History of Changes
Other Study ID Numbers: CA0005/09
Study First Received: June 8, 2006
Last Updated: December 18, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on October 16, 2012