Plain-English translation of NCT03821129 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Stroke research guide →This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This study tests the GORE® CARDIOFORM Septal Occluder, a small device that is implanted in the heart to close an opening called a patent foramen ovale (PFO). PFO is a common heart condition where a small hole between the upper chambers of the heart allows blood clots to pass through, sometimes causing stroke. This trial will follow people who receive this device along with blood-thinning medication to see if it can prevent strokes from happening again.
Some people have strokes that doctors cannot trace to a clear cause, but later find out they have a PFO. This trial exists to confirm that closing this heart opening with this medication is an effective way to stop future strokes from occurring.
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You will receive the GORE® CARDIOFORM Septal Occluder device implanted in your heart during a procedure, along with blood-thinning medication to take by mouth. After the procedure, you will return to the research center for follow-up visits at 1 month, 6 months, 12 months, and then once a year for up to 5 years. During these visits, doctors will check on how you are healing and monitor for any problems.
AI-generated summary from trial data · Aug 2, 2026 · Not medical advice
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