A Study Comparing the Safety and Effectiveness of the Encore PFO Closure Device to Other FDA-Approved Devices in Adults Aged 18 to 60 with Cryptogenic Stroke

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and noninferiority of the Encore PFO closure device compared to any FDA-approved PFO closure device chosen by investigators. The study focuses on patients who have had a cryptogenic stroke caused by a presumed paradoxical embolism and involves closing a patent foramen ovale PFO through a percutaneous, transcatheter procedure. This prospective, multicenter, randomized clinical study aims to provide reasonable assurance of the Encore devices safety and effectiveness. Participants will be randomly assigned to receive either the Encore PFO closure device, which includes an implant component and a single-use delivery system, or an FDA-approved PFO closure device selected by the investigator. The procedure involves using these devices to close the PFO via catheter-based delivery. The study design includes comparison of procedural and device-related outcomes between these two groups. During the study, participants will be monitored for safety, including the incidence of serious adverse events related to the device or procedure within 6 months. Effectiveness will be assessed by measuring the success of PFO closure at 6 months. Additional evaluations include long-term monitoring for recurrent stroke, transient ischemic attacks, new atrial arrhythmias, and procedural success over 5 years. Participants will undergo imaging, neurological assessments, and follow-up visits to track outcomes and overall safety throughout the study period.

Encore PFO Closure Device - The PerFOrm Trial