Plain-English translation of NCT04919980 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-stage trial is testing a new device called the INNOVALVE system that replaces a leaky mitral valve without requiring traditional open-heart surgery. The device is designed for patients who have significant mitral valve leakage and are too high-risk for conventional surgery. This study will evaluate whether the INNOVALVE system is safe and works as intended.
Many people with a leaky mitral valve need surgery to fix it, but some are too frail or have other health conditions that make traditional open-heart surgery too dangerous. This trial exists to see if the new treatment can help these patients safely without the risks of conventional surgery.
You likely qualify if…
You likely don't qualify if…
If you qualify, you would undergo a procedure where doctors use a catheter (thin tube) to place the new INNOVALVE device to replace your leaky mitral valve, avoiding traditional open-heart surgery. You would then be followed closely by the research team with regular visits and heart imaging to monitor how well the device is working and check for any side effects. The study will track your health and symptoms over time to determine if this new treatment is safe and effective.
AI-generated summary from trial data · Jul 10, 2026 · Not medical advice
United States