ATLAS (AltaValve) Pivotal Trial is a study to see how safe and effective the AltaValve System is for people with mitral regurgitation. This condition happens when the heart's mitral valve doesn't close tightly, letting blood flow backward in the heart. The trial is for adults 18 and older who have symptoms like shortness of breath (NYHA class II-IV) and have tried other medicines. Participants can't have surgery or another procedure called TEER. They should not be in other clinical trials or have serious allergies, and they can't be pregnant.
- The study checks how well the AltaValve System works and if it's safe.
- Participants need to meet certain health criteria to join.
- There are specific reasons someone might not be able to join, like being in another trial or having certain allergies.