AMPLATZER PFO Occluder Post Approval Study

Inclusion Criteria: • Subjects with a PFO who have had an ischemic stroke within the last 547 days Exclusion Criteria: * Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a ≥ 50% lumen diameter supplying the involved lesion * Intra-cardiac thrombus or tumor * Documented evidence of venous thrombus in the vessels through which access to the PFO is gained * Acute or recent (within 6 months prior to consent) myocardial infarction or unstable angina * Left ventricular aneurysm or akinesis * Mitral valve stenosis or severe mitral regurgitation requiring intervention irrespective of etiology * Aortic valve stenosis (mean gradient \>40 mmHg) or severe aortic valve regurgitation * Mitral or aortic valve vegetation or prosthesis * Aortic arch plaques protruding greater than 4mm into the aortic lumen * Left ventricular dilated cardiomyopathy with depressed left ventricular ejection fraction (LVEF less than 35%) * Subjects with other source of right to left shunts, including an atrial septal defect and/or fenestrated septum * Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter * Pregnancy at the time of implant * Age less than 18 years or greater than 60 years at time of consent * Active endocarditis or other untreated infections * Organ failure (kidney, liver or lung). Kidney failure: Poor urine output of less than 1 cc/kg/hr with elevated BUN levels (above the normal reference range for the laboratory at the inve…