The foramen ovale is an opening between the left and right side of the heart that usually closes during fetal development but may remain patent (open) in up to 25 percent of adults. A patent foramen ovale (PFO) can allow blood to shunt from the right to the left side of the heart, meaning that blood clots from the venous circulation have a direct pathway into the arterial circulation. This can result in thromboembolic events, e.g., stroke or transient ischemic attack (TIA or “mini-stroke”). This trial randomizes patients to device for closure of the PFO or medical therapy.
To be eligible for participation in this trial you must:
- Be between 18 and 60 years of age
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Have had a positive study showing right to left shunting through PFO
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Be available for follow-up in accordance with the protocol
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Have experienced clinical TIA or stroke within the past three months
This is a partial list of eligibility requirements.