The ENCIRCLE Trial is a study to check if a new heart device, called the SAPIEN M3 System, is safe and works well for people with a heart problem called mitral regurgitation (MR). This means the heart's mitral valve doesn't close properly, letting blood flow the wrong way. The study focuses on patients who can't have regular heart surgery or other treatments.

In this prospective single-arm, multicenter study, only one group of people will receive the SAPIEN M3 System. To join, you must be 18 or older and have at least a 3+ level of MR. You should also have heart problems that make regular treatments unsuitable. Your heart care should already be at its best for at least 30 days before joining. You need to agree in writing after understanding the study.

• The study has specific rules about who can or can't join, based on your heart and general health.
• You might not be able to join if you have other serious health issues or recent heart procedures.
• To take part, it's essential to be stable health-wise and discuss potential risks and benefits with your doctor.