Study of GOREae CARDIOFORM Septal Occluder and Antiplatelet Therapy to Prevent Recurrent Stroke in Adults With Patent Foramen Ovale PFO

What this Trial Is About

This research evaluates the safety and effectiveness of the GORE4 CARDIOFORM Septal Occluder device in adults who have had an ischemic stroke thought to be caused by a patent foramen ovale PFO, a heart condition. The study aims to assess device performance and the quality of operator training in real-world, post-approval settings. Up to 636 adults aged 18 to 70 will participate across up to 40 U.S. centers. Participants will receive the GORE4 CARDIOFORM Septal Occluder to close the PFO, combined with antiplatelet medical management. The device is commercially available and implanted as a one-time procedure. After implantation, participants will be followed for up to 5 years with scheduled visits at 1 month, 6 months, 12 months, and annually thereafter. Throughout the study, participants will undergo assessments including echocardiographic examinations to evaluate PFO closure and residual shunts, monitoring for new atrial arrhythmias, and tracking serious adverse events related to the device or procedure. The main outcomes include measuring the proportion of participants experiencing recurrent ischemic stroke up to 24 months after implantation and safety events within 30 days. This long-term follow-up allows careful evaluation of device performance and participant health over time.

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