This study looks at the safety and effectiveness of a medical device called the GORE® CARDIOFORM Septal Occluder. It helps people with a condition called Patent Foramen Ovale (PFO), which is a small hole in the heart. The study will also see how well doctors are trained to use this device. Up to 636 adults will join from various U.S. centers. Participants will have check-ups at 1 month, 6 months, 12 months, and then once a year for 5 years after getting the device.

To participate, you must have had a specific type of stroke in the past year and be able to take certain medicines called antiplatelet therapy. People with heart issues like atrial fibrillation or other health problems, such as uncontrolled diabetes or high blood pressure, cannot join. Pregnant women or those planning to become pregnant soon are also excluded.

• The study lasts up to 5 years with several follow-up visits.
• Participants need to tolerate antiplatelet therapy.
• Certain health conditions may exclude participation.