Patients with history of stroke or TIA and diagnosis of a PFO needed for PFO closure.
GORE® HELEX™® Septal Occluder/GORE® Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients with Patent Foramen Ovale (PFO), The GORE REDUCE Study
UVa Health System, Division of Internal Medicine, Department of Neurology, seeks women and men, ages 18 to 59 with a patent foramen ovale (PFO) and a history of a stroke or transient ischemic attack (TIA) for an unknown reason. The purpose of the study is to see if closing the PFO with an investigational device [Gore-Helex Septal Occluder] along with taking a blood thinning drug is as good as only taking a blood thinning drug at reducing the risk of another stroke or TIA. Study participants are assigned to one of 2 groups: a PFO closure procedure and blood thinning drug or only a blood thinning drug. The study also involves x-rays, an MRI and ECGs. After the possible PFO closure procedure there are 5 follow-up clinic study visits over 2 years and then a follow-up telephone call once a year for 3 years. There is no compensation is provided for this study. Contact Information: For more information please contact: " Linda Bailes, RN " (434) 982-1058 or firstname.lastname@example.org " IRB-HSR #14012 Principal Investigator: Dr. Nina Solenski