Feasibility Clinical Study of the Ovalis, Inc. Patent Foramen Ovale (PFO) Closure System in Patients with Cryptogenic Neurologic Events, Migraines, and Decompression Illness

This study is testing a new device designed to close a small hole in the heart called a Patent Foramen Ovale (PFO). A PFO is an opening between the upper chambers of the heart that normally closes at birth. When it stays open, blood clots can potentially pass through it and cause a stroke or other problems. The device is inserted through a vein (not open heart surgery) and is designed to plug the hole permanently. The study is evaluating whether this new closure device is safe and can be used effectively. You may be eligible if: - You are between 18 and 65 years old - You have been confirmed to have a PFO with blood flow passing through it from right to left - You have a history of: stroke or mini-stroke (TIA), blood clots passing from right to left heart, low blood oxygen in the right side of the heart, severe decompression illness (from scuba diving or flying), OR severe migraines not responding to medication You may NOT be eligible if: - You have a mass (clot or tumour) inside a blood vessel or your heart - You have a large hole (atrial septal defect) in your heart - You have a bleeding disorder, severe kidney problems, or unstable blood pressure - You have recently had a heart attack, stroke, or mini-stroke - You have had a head injury or seizures Talk to your doctor about whether this trial might be right for you.