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

Clinical Trial Title: 
Gore® 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 ID: 
Clinical Trial Investigator Name: 
Clifford J. Kavinsky, MD, PhD
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. 

Clinical Trial Area: 
Heart and Vascular Conditions
Stroke and Cerebrovascular Disease
Contact Phone: 
(312) 942-3542
Contact Name: 
Angelise Stephens