Plain-English translation of NCT06465745 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 a new device called the AltaValve System, which is designed to repair a leaky mitral valve (the valve on the left side of your heart) without open-heart surgery. The study will enroll about 450 people with moderate-to-severe or severe mitral valve leakage who have already tried medical therapy but still have symptoms, and who are not good candidates for surgery or another catheter-based repair option. Researchers want to learn whether this treatment is safe and works well for people in two groups: those without significant calcium buildup in the valve area, and those with more calcium buildup.
Many people with a severely leaky mitral valve have few treatment options because they are too sick for traditional open-heart surgery or do not qualify for the only other catheter-based repair procedure currently available. This trial exists to see if the AltaValve device can offer a safe and effective new option for these patients.
You likely qualify if…
You likely don't qualify if…
If you qualify, you will receive the AltaValve device through a catheter-based procedure (similar to how doctors insert stents), which is less invasive than open-heart surgery. You will have clinic visits to monitor your recovery and make sure the device is working properly. The trial will follow you over time to track how well the treatment works and whether you experience any side effects, with particular attention to how your symptoms improve and how well your heart valve functions.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
United States