Plain-English translation of NCT04686253 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Many people have a small hole in their heart called a patent foramen ovale (PFO) that usually causes no problems. However, researchers believe it may be connected to strokes, mini-strokes, and migraines in some patients. This study is investigating how the structure of this hole inside the heart relates to these conditions, and whether closing it with a catheter-based procedure can help.
Doctors know that PFO can sometimes allow clots or other particles to travel from the veins into the arteries (a process called paradoxical embolism), potentially triggering strokes or migraines. However, they don't fully understand the internal features of the hole that make it risky. This trial aims to map those features in detail so doctors can better predict who needs treatment and whether closing the hole will actually help.
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Depending on which group you join, you will either receive a catheter-based procedure to close your heart hole (if you have had a stroke, mini-stroke, or migraine) or be followed for 5 years without treatment (if you have no symptoms). All participants will have blood samples drawn from different heart chambers during the procedure, heart imaging scans, and special testing to measure blood flow through the hole. Researchers will track your symptoms and imaging results over time to understand how the structure of your heart hole relates to your condition and whether closing it helps.
AI-generated summary from trial data · Jun 1, 2026 · Not medical advice
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