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PFO PAS is a singel arm, multinational post-market study in patients with PFO after ischemic stroke (paradoxical embolism). Screening via PFO colloquium.
Study Objectives; To demonstrate safety of the Amplatzer PFO Occluder and Amplatzer Talisman PFO Occluder by assessing the 30-day rate of device- or procedure-related serious adverse events including those that led to death.
To demonstrate that the Amplatzer PFO Occluder and Amplatzer Talisman PFO Occluder are effective by assessing the rate of recurrent ischemic stroke through 5 years. To demonstrate effectiveness of the training program for new operators.
Study designe; Conducted in approximately 100 centers in the U.S., Canada, and Europe.
1,214 subjects will be included in the effectiveness endpoint analysis population.
Subjects will be followed for 5 years post implant according to the following schedule: pre-hospital discharge, 1 month, 6 months, 12 months, and annually thereafter though 5 years post implant.