Evaluating the Recross P3 Occluder Device for Closing Heart Openings in Adults Who Have Had a Stroke

What this Trial Is About

Researchers are evaluating the Recross P3 Occluder System, a new heart device designed to close a small opening between the upper chambers of the heart called a Patent Foramen Ovale PFO. This trial focuses on adults aged 18 to 65 who have had a stroke that might be related to this heart opening. The main goal is to determine if the P3 Occluder System is safe and effective at closing the PFO to reduce the risk of another stroke. Participants will undergo a procedure to implant the P3 Occluder device if appropriate. After the procedure, they will have follow-up visits with their doctor at 1 month, 3 months, 6 months, 1 year, and 5 years to check their progress and device status. Additionally, study staff will contact participants by phone at 2, 3, and 4 years after the procedure to complete surveys. During the study, participants will be monitored for major heart-related events within 30 days and assessed for effective closure of the PFO at 6 months. Other safety evaluations include checking for serious device- or procedure-related events. The study also examines if the device remains correctly positioned at 6 months. Overall, participants will be involved in regular doctor visits, imaging tests, and surveys for up to 5 years to ensure thorough monitoring of their heart health and device performance.

Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study