Clinical Trial TitleGore® Cardioform Septal Occluder and antiplately medical management for reduction of recurrent stroke in patients with patent foramen ovale (PFO): The REDUCE post approval study.
Clinical Trial Protocol Description:
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.
Clinical Trial Eligibility Criteria:
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.