The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
A maximum of 1214 adult subjects will be enrolled at up to 100 centers in the U.S. and Canada. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant.
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Subjects with a PFO who have had an ischemic stroke within the last 547 days;
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Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a >50% lumen diameter supplying the involved lesion;
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Intra-cardiac thrombus or tumor;
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Documented evidence of venous thrombus in the vessels through which access to the PFO is gained;
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Acute or recent (within 6 months prior to consent) myocardial infarction or unstable angina;
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Left ventricular aneurysm or akinesis;
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Mitral valve stenosis or severe mitral regurgitation requiring intervention irrespective of etiology;
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Aortic valve stenosis (mean gradient >40 mmHg) or severe aortic valve regurgitation;
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Mitral or aortic valve vegetation or prosthesis;
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Aortic arch plaques protruding greater than 4mm into the aortic lumen;
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Left ventricular dilated cardiomyopathy with depressed left ventricular ejection fraction (LVEF less than 35%);
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Please contact study team for additional inclusion/exclusion criteria;
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Cardiovascular Abnormalities
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Heart Defects, Congenital
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Heart Septal Defects, Atrial
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