GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
Status:
Completed
Trial end date:
2020-05-11
Target enrollment:
Participant gender:
Summary
The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE®
HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical
management is safe and effective and reduces the risk of recurrent stroke or
imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical
management alone in patients with a PFO and history of cryptogenic stroke or
imaging-confirmed TIA.
A co-primary objective is to demonstrate that medical management plus closure with the study
device reduces the risk of new brain infarct compared to medical management alone.