Plain-English translation of NCT05895487 on ClinicalTrials.gov ↗ ·
This is an observational study tracking 2,000 patients across Russia who have had heart valve replacement surgery using the UniLine prosthesis, a biological heart valve made from animal tissue. Researchers want to understand how well this valve performs, how safe it is, and how long it lasts in patients' hearts over many years of follow-up.
Heart valve disease is a serious condition that affects many people and can lead to heart failure. While biological heart valves like UniLine are promising because they don't require long-term blood-thinning medications and have good blood flow characteristics, doctors need long-term data from real patients to confirm the valve stays durable and safe over time.
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As a participant, you would be followed over time with regular medical visits and heart imaging tests to monitor how your new valve is working. Researchers will collect information about your symptoms, heart function, any complications, and how well you're doing in daily life. This is not a treatment study — you have already had your valve replaced — but rather a study that tracks your long-term outcomes through existing medical care and records.
AI-generated summary from trial data · Jul 10, 2026 · Not medical advice
Russia