Plain-English translation of NCT04905017 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 early feasibility study is testing the Trisol System, a new medical device designed to treat tricuspid regurgitation—a condition where blood leaks backward through a valve on the right side of your heart. The device is placed through a minimally invasive catheter procedure (meaning doctors guide it through your blood vessels rather than performing open-heart surgery). This trial will enroll about 30 patients to see if the Trisol System is safe and effective for people who have moderate to severe tricuspid regurgitation and are considered too high-risk for traditional valve surgery.
Tricuspid regurgitation can cause serious symptoms like shortness of breath and fatigue, but many patients with this condition are too sick or frail to safely undergo traditional open-heart surgery. This trial exists to test whether the Trisol System offers a safer, less invasive option for these high-risk patients.
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If you are enrolled, you will undergo the Trisol System procedure, which is performed through a catheter inserted via the jugular vein in your neck—avoiding the need for open-heart surgery. Your doctors will guide the device into position using imaging guidance. After the procedure, you will attend follow-up visits to have your heart monitored with imaging tests and clinical assessments to evaluate how well the device is working and to watch for any side effects.
AI-generated summary from trial data · Aug 9, 2026 · Not medical advice
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