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Sponsored by: |
Cierra |
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Information provided by: | Cierra |
ClinicalTrials.gov Identifier: | NCT00196040 |
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.
Condition | Intervention |
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Foramen Ovale, Patent |
Device: PFX Closure System |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Feasibility Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness |
Estimated Enrollment: | 60 |
Study Start Date: | October 2005 |
Study Completion Date: | November 2007 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects with one or more of the following:
Additional Inclusion Criteria for Migraine Subjects:
Exclusion Criteria:
Additional Exclusion Criteria for Cryptogenic Stroke Subjects:
Additional Exclusion Criteria for Migraine Subjects:
Germany | |
Cardiovascular Center Frankfurt Sankt katharinen | |
Frankfurt, Germany, 60389 |
Principal Investigator: | Horst Sievert, MD | Cardio Vasculares Centrum - Sankt Katharinen |
Study ID Numbers: | 2005-002 |
Study First Received: | September 12, 2005 |
Last Updated: | December 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00196040 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Ischemic Attack, Transient Heart Septal Defects Heart Diseases Cardiovascular Abnormalities Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Ischemia |
Brain Diseases Cerebrovascular Disorders Heart Septal Defects, Atrial Migraine Disorders Foramen Ovale, Patent Brain Ischemia Congenital Heart Septum Defect Congenital Abnormalities Heart Defects, Congenital |
Ischemic Attack, Transient Heart Septal Defects Heart Diseases Cardiovascular Abnormalities Nervous System Diseases Vascular Diseases Central Nervous System Diseases Brain Diseases |
Cerebrovascular Disorders Heart Septal Defects, Atrial Foramen Ovale, Patent Brain Ischemia Cardiovascular Diseases Congenital Abnormalities Heart Defects, Congenital |