To demonstrate safety of the AMPLATZERTM PFO Occluder by assessing the 30-day rate of device- or procedure-related serious adverse events including those that led to death and the effective by assessing the rate of recurrent ischemic stroke through 5 years
This is a single arm, multi-center study to confirm the safety and effectiveness of the AMPLATZERTM PFO Occluder in the post approval setting
Subjects with a PFO who have had an ischemic stroke within the last 270 days, have undergone investigation by a neurologist to exclude known causes of ischemic stroke, and have therefore been determined to have had a cryptogenic stroke (i.e., stroke from an unknown cause) assessed by a neurologist within the last 270 days, with stroke defined as follows: acute focal neurological deficit, presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT findings of a new, neuroanatomically relevant, cerebral infarct.
IV - Research Studies occurring after FDA has approved a drug for marketing. These studies gather additional information about a drug's safety, efficacy, or optimal use.
Memorial Hospital Central
Protocol Number: 19-6502
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