This study is testing a device called the AltaValve to see if it's safe and works well for people with a heart problem called mitral valve regurgitation. This means their heart valve doesn't close properly, letting blood flow backward. The study is for people who can't have regular heart surgery because it's too risky for them.
To join, you need to be at least 18 years old and have symptoms like tiredness or shortness of breath due to your heart condition. You can't participate if you have trouble understanding the study, are in another study already, or have certain allergies. If you have other serious health problems or are pregnant, you also can't join.
- This is a single-arm study, meaning everyone gets the same treatment.
- You'll need approval from a heart team, including a surgeon and a heart doctor.
- The study takes place at multiple locations.