This study is testing the safety and effectiveness of a new device called the SAPIEN M3 System for people with significant mitral regurgitation (MR), a condition where a heart valve doesn't close properly. You might be able to join if you are 18 or older, have severe MR (at least 3+), and your heart failure symptoms are affecting your daily life (NYHA functional class II or higher). This trial is for people whose doctors have decided that standard surgery or other catheter-based treatments are not suitable for them. The main goal is to see how many people experience death or need to be re-hospitalized for heart failure within one year after receiving the SAPIEN M3 valve and dock. The study is currently enrolling participants.

Study design

This is a single-arm study, meaning all 900 participants will receive the SAPIEN M3 valve and dock. It is a multicenter study, conducted at multiple locations.

What's involved

During the procedure, you will have a SAPIEN M3 dock and a SAPIEN M3 valve implanted through a transseptal approach (a way to access the heart through a vein).

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for one year to measure outcomes like death and rehospitalization for heart failure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.