Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
W.L.Gore & Associates
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Presence of cryptogenic ischemic stroke or TIA of presumed embolic infarction verified by a neurologist within 180 days prior to randomization
Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.
Absence of an identifiable source of thromboembolism in the systemic circulation
No evidence of a hypercoagulable state
You may not be if
Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, atrial fibrillation/flutter, cardiac prosthetics (valves), mitral valve stenosis, aortic dissection, significant atherosclerosis, vasculitis, pre-existing neurologic disorders, multiple sclerosis, arteriovenous malformations, prior intracranial hemorrhage, severe central nervous system (CNS) disease, severe disability related to prior stroke, and autoimmune disorders that would increase the risk of mortality or morbidity above what is typical for the treatment
Previous Myocardial Infarction
Active infection that cannot be treated successfully prior to randomization
Sensitivity or contraindication to all proposed medical treatments
Pregnancy or intent on becoming pregnant through 24-months after randomization
Indications outside the parameters accepted for placement of the GORE® HELEX® Septal Occluder / GORE® Septal Occluder, including extensive congenital cardiac anomalies and defect diameter estimated to be \> 18mm
Atrial septal anatomy that is expected to necessitate placement of more than one GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder
Need for concomitant procedure(s) that may confound detection of adverse events related to device placement
