Plain-English translation of NCT07586995 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This trial is checking how safe and effective the TriClip System is when used in actual hospital settings around the world. The TriClip System is a small clip device placed on the heart valve to reduce leakage in patients with tricuspid regurgitation (a condition where blood leaks backward through one of the heart's valves). Researchers will follow 1,000 patients for up to five years after the procedure to make sure the device works as expected and doesn't cause unexpected problems.
After a medical device is approved for use, companies must continue monitoring how well it performs and how safe it is when used in everyday clinical practice. This study exists to confirm that the clip device continues to work reliably and safely in real-world situations across many different hospitals and patient populations.
You likely qualify if…
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You will undergo the TriClip procedure as part of your standard care. After the procedure, you'll have follow-up visits at discharge, 30 days, 6 months (by phone), 12 months, and then yearly through 5 years. These visits will include heart imaging tests (echocardiograms) to check how well the device is working. If you also join the imaging substudy, you'll have additional CT scans at baseline and at 12 months to assess how your heart is healing.
AI-generated summary from trial data · Aug 18, 2026 · Not medical advice
United States
Italy
Spain