Plain-English translation of NCT04408430 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 Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA heart valves in patients with severe mitral valve disease and heavily calcified heart valve tissue. These special valves are placed using a catheter (a thin tube) rather than open-heart surgery, which may be safer for patients who are too ill or frail to undergo traditional surgery. The study will measure whether this treatment is safe and whether it improves patients' symptoms and quality of life.
Many patients with severe mitral valve disease cannot safely have traditional open-heart surgery because of their age, other health conditions, or the condition of their heart. This trial exists to see if a less invasive catheter-based approach using specially designed valves can help these patients who have few other treatment options.
You likely qualify if…
You likely don't qualify if…
If you are accepted into the treatment group, you will undergo a catheter procedure to have the new valve placed in your heart—this is done without open-heart surgery. You will then attend follow-up visits at regular intervals (including annual visits) for 5 years to allow doctors to monitor how well the valve is working and how you are feeling. If you are in the comparison group (receiving medical treatment only), you will continue taking medications for your heart condition and may have periodic evaluations to track how your disease progresses over time.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
United States