GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

Prior treatment

• Previous Myocardial Infarction
• Active infection that cannot be treated successfully prior to enrollment
• Need for concomitant procedure(s) that may confound detection of adverse events related to device placement

Other illness

• History of or ongoing atrial fibrillation/flutter
• Neurological deficits not due to stroke that may affect the patient's neurologic assessments
• Evidence of hypercoagulable state, Uncontrolled diabetes mellitus, uncontrolled systemic hypertension or pulmonary hypertension at the time of screening or procedure
• Indications outside the parameters accepted for placement of GSO, including extensive congenital cardiac anomalies and defect diameters considered too large for closure with the device.

Lab values

• Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, cardiac prosthetics (valves), severe native valve disease (including mitral valve stenosis), severe ventricular wall motion abnormalities, aortic dissection, significant atherosclerosis, vasculitis, pre-existing non-vascular neurologic disorders, pulmonary arteriovenous malformations, prior intracranial hemorrhage, severe disability related to prior stroke, autoimmune disorders that would increase the risk of stroke or thromboembolism, or associated with increased risk of infection or procedural complications, in the opinion of the investigator, left ventricular ejection fraction of \<40%, coexistent cause or intra-cardiac shunting (e.g. VSD or ASD)

Other

• Rankin Scale sore greater than or equal to 3 at the time of procedure
• Sensitivity or contraindication to all proposed medical treatments or any device components
• Pregnant, lactating, or intent on becoming pregnant through 24 months after enrollment.
• Atrial septal anatomy that is expected to necessitate placement of more than one GORE® CARDIOFORM Septal Occluder
• Note: Additional Exclusion Criteria may apply

• Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) verified by a neurologist within the last 365 days prior to enrollment.
• Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE) and/or transcranial Doppler (TCD), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.
• Patient is able to tolerate antiplatelet therapy
• Note: Additional Inclusion Criteria may apply