Patent Foramen Ovale in Stroke Patients
Protocol: SITE00000199
Full Title
GORE CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
This study enrolls adults who have have a patent foramen ovale (PFO) and have had a stroke. The purpose of this study is to look at closing the PFO to reduce your risk for another stroke using a market-approved medical device called a septal occluder.

A PFO is a common opening in the wall between the two upper chambers of your heart. Usually this opening closes around the time of birth, but if it stays open after birth it can allow the blood to mix in the two upper chambers of the heart. In most people, leaving the opening untreated has no negative consequences. However, in some patients who have had a stroke of unknown origin, having a PFO may increase the risk of having another stroke if the opening is left untreated.

This study takes place over about 5 years. We will use a FDA-approved device called a septal occluder to close your PFO. The study involves a screening visit, surgical procedure to close your PFO, and follow up visits and phone calls. Study takes place at the UBMD Cardiovascular Medicine clinic, UBMD Neurology Clinic and the UB Clinical Research Center (875 Ellicott, Buffalo, NY 14203).

Technical Description

The purpose of the GORE CARDIOFORM Septal Occluder
(GSO device) post-approval study is to assess the safety and effectiveness of GSO device as observed in the REDUCE pivotal IDE study, and to evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.
Compensation: No
Adults ages 18-70.
Patient has been evaluated by a neurologist and diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) within the last 365 days prior to enrollment.
Patient has presence of a patent foramen ovale (PFO).
Age Group: Adults
Principal Investigator: VIJAY IYER Open Study
+1 716-888-4713
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