Plain-English translation of NCT06581471 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 trial is testing the TRiCares Topaz Tricuspid Valve Replacement System, a new device designed to replace a damaged tricuspid valve (one of your heart's four valves) without open-heart surgery. Instead of major surgery, doctors insert this replacement valve through a catheter — a thin tube — and position it in your heart. The study is evaluating whether this new treatment is safe and works well for people with severe tricuspid valve leakage.
Many people with severe tricuspid valve disease are too fragile or at too high risk for traditional open-heart surgery. This trial exists to see if this new catheter-based approach can offer these patients a safer alternative to fix their leaky valve and improve their heart function.
You likely qualify if…
You likely don't qualify if…
If you qualify, you would undergo the catheter-based valve replacement procedure at one of the study hospitals. The procedure itself involves inserting a thin catheter through a blood vessel to deliver the new valve to your tricuspid valve. After the procedure, you would be followed closely by the study team through visits and tests to monitor how well the new valve is working and to track your overall health and recovery.
AI-generated summary from trial data · Aug 30, 2026 · Not medical advice
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