This study is testing a new device, the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement system, for people with very bad mitral regurgitation (MR), a condition where the heart valve doesn't close properly, causing blood to flow the wrong way. The study focuses on those who can't have traditional surgery due to high risks. The device is a special valve that can be placed in the heart through a less invasive procedure. The study aims to see if the device is safe and works well within 30 days and over a longer period.
- Participants must be 18 or older and have severe MR.
- The study is open-label, so everyone knows they're getting the device.
- Participants will be evaluated at 30 days and then over a longer time for effects.
Some people can't join, like those with certain heart conditions or recent surgeries. If you're interested and meet the criteria, this could be a chance to try a new treatment option.
How understandable was the trial content above?
Hard to understand
Easy to understand