This study tests a new heart device called the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System. This device is for people with severe mitral regurgitation, a condition where the heart's mitral valve doesn't close properly, causing blood to flow backward. This study is for patients who are high-risk for surgery. The HighLife system is placed in the heart through a small tube (catheter) rather than surgery.

The study will check if the device is safe and works well, with a main focus on results after 30 days. You can join if you're 18 or older, have severe mitral regurgitation, and have been treated for heart failure symptoms but can't have surgery. However, you can't join if you have other serious heart problems or have had certain heart procedures recently.

• The study is open to patients with severe mitral valve issues who can't have surgery.
• The device is inserted through a catheter, not surgery, to replace the faulty valve.
• The study will evaluate the device's performance and safety over time.