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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.
Full 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; we propose to use a non-implantable system to safely effect closure.
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Inclusion criteria
Subject is between 18 and 65 years old
Documented patent foramen ovale as determined by positive micro bubble study demonstrating right to left shunt and/or anatomic detection and functional assessment by pre-operative transcranial Doppler (TCD) and peri-operative echocardiography or ultrasound.
Subjects with one or more of the following:
Negative pregnancy test in women who are of child-bearing potential
Signed Informed Consent form
Additional Inclusion Criteria for Migraine Subjects:
Exclusion criteria
Additional Exclusion Criteria for Cryptogenic Stroke Subjects:
Additional Exclusion Criteria for Migraine Subjects:
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Data sourced from clinicaltrials.gov
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