Demonstrate that patent foramen ovale (PFO) closure with GORE® HELEX® Septal Occluder / GORE® 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.
HLX 06-03 is a prospective, randomized, multicenter, multinational clinical trial. Approximately 664 subjects will be randomized to either the test or control arm using a 2:1 randomization scheme. A maximum of fifty (50) Investigational Sites in the United States and European Countries will participate in the study with no per-site subject limit. The anticipated accrual rate is approximately 15 subjects per month for a total accrual period of approximately 44-48 months. Randomized subjects will be followed for 60 months with follow-up evaluations at 1, 6, 12, 18, 24, 36, 48, and 60 months.