Evaluating the Recross P3 Occluder System for Closing Patent Foramen Ovale to Reduce Stroke Risk in Adults

What this Trial Is About

Researchers are evaluating a new heart device called the Recross P3 Occluder System in adults aged 18 to 65 who have a small opening between the upper chambers of the heart Patent Foramen Ovale or PFO and have experienced a stroke potentially linked to this heart opening. The study aims to determine if the P3 Occluder System is safe and effective for closing the PFO to reduce the risk of another stroke. Participants who qualify will undergo a procedure to implant the P3 Occluder System. The study includes follow-up visits with their doctor at 1 month, 3 months, 6 months, and 1 year after the procedure. Additionally, participants will receive phone calls from the study staff at 2 and 3 years after the procedure to complete surveys. During the study, participants will have exams to monitor the closure of the PFO and check for any cardiovascular events or complications. The main outcomes measured include effective closure of the PFO at 6 months and any adverse cardiovascular events within 30 days after the procedure. Researchers will also track device position and serious adverse events up to 6 months. The total participation may last up to 3 years with periodic assessments and surveys.

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