Plain-English translation of NCT04898335 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This is a registry study that tracks patients who have received the Tendyne Mitral Valve System, a new artificial valve designed to treat severe leaking of the mitral valve in the heart. Researchers want to learn how well this treatment works in everyday patients and whether it is safe by collecting information from hospitals across Europe over several years.
Many older patients or those with serious health conditions cannot have traditional open-heart surgery to fix or replace a leaking mitral valve. This study exists to understand how well this newer, less invasive valve option performs in real patients so doctors can make better treatment decisions.
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If you join, your doctors will share your medical records and imaging results (like heart ultrasounds and CT scans) from your valve procedure and follow-up visits with the research team. You will be followed for up to 3 years after your procedure, with assessments at 30 days, 1 year, and 3 years to track how you are doing and how well the valve is working. No additional procedures or hospital visits beyond your normal care are required — the study simply observes and records information from your existing medical care.
AI-generated summary from trial data · Sep 5, 2026 · Not medical advice
Austria
Belgium
France