Treatment Study for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale

The purpose of the Gore® Cardioform Septal Occluder (GSO device) post-approval study is to assess the continued safety and effectiveness of the FDA-approved GSO device for patent foramen ovale (PFO) closure, and to evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

In order to participate you must meet the following criteria:

• Have a patent foramen ovale (PFO).
• Have a history of embolic stroke of undetermined source (ESUS) within 365 days prior to enrollment.
• Are 18-70 years old.

You will be excluded from the study if any of the following criteria apply to you:

• Have a history of or ongoing a-fib.
• Have had a previous heart attack.

This is a partial list of inclusion and exclusion criteria.