Plain-English translation of NCT05537753 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This study is testing whether the Encore PFO closure device—a small medical device placed through a catheter to close a hole in the heart—is safe and effective for people who have had a stroke. The trial will compare this new device against other FDA-approved devices already in use for the same purpose. Researchers want to see if the Encore device works as well as or better than existing options.
Many strokes happen without a clear cause, and some of these may be linked to a small hole in the heart called a PFO. Closing this hole with a device can help prevent future strokes. This trial exists to prove that the Encore device is a safe and effective option for this treatment.
You likely qualify if…
You likely don't qualify if…
If you qualify, you will be randomly assigned to receive either the new Encore device or another FDA-approved PFO closure device. The procedure itself involves inserting a thin tube (catheter) through a blood vessel and guiding it to your heart to place the device. You will have heart imaging tests before and after the procedure to confirm the device is working properly, and you will be monitored during follow-up visits to track your recovery and any side effects.
AI-generated summary from trial data · Aug 12, 2026 · Not medical advice
United States