This study looks at how safe and effective a new medical device is for people with a heart problem called **tricuspid regurgitation**. This condition happens when the heart's tricuspid valve does not close well, causing blood to flow backward. The device being studied is called the DUO System, which is a **transcatheter valve**. This means it is put into the heart without open-heart surgery, using a thin tube called a catheter.

The study will take place at several locations and will follow patients for up to five years. To be part of the study, participants must be 18 or older, have severe tricuspid regurgitation, and not be helped by medicine alone. They should also be approved by a team of heart doctors.

• The study lasts up to five years with multiple visits.
• Participants must have severe tricuspid regurgitation and be 18 or older.
• Patients will be checked for safety and device function.