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AMPLATZERTM PFO Occluder Post Approval Study

Primary Objective

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

Study category: Brain and Nervous System

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Description

This is a single arm, multi-center study to confirm the safety and effectiveness of the AMPLATZERTM PFO Occluder in the post approval setting

Details
Age

Adult

Eligibility

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.

Phase

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.

Type of Study

Other

Scope

National

Location

Memorial Hospital Central

Principal Investigator
Cihan Cevik

Cihan Cevik

Study ID

Protocol Number: 19-6502

More information available at ClinicalTrials.gov: NCT03309332

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