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- (EMPOWER) Assessment of the Carillon Mitral Contour System
Clinical Trial
(EMPOWER) Assessment of the Carillon Mitral Contour System
Heart failure is a condition known as the heart's inability to pump a sufficient amount of blood to meet a person's body requirements. One of the consequences of heart failure can be mitral valve regurgitation. This occurs when the bottom left part of the heart (left ventricle) is stretched out to the point the mitral valve located above the ventricle is stretched out as well. The stretching of the valve causes it to leak, otherwise known as functional mitral valve regurgitation. The leaking can lead to decrease cardiac output, higher pressure in other parts of the heart, and further stretching of the ventricle. This study would investigate a new device called the CARILLON mitral contour system. this device would tighten the mitral valve to help reduce or stop its functional regurgitation. Heart failure patients with moderately severe to severe functional mitral valve regurgitation will be sorted into one of two groups: device or control. The procedure is done with general anesthesia in the EP lab and is placed via a catheter through the groin. Patients will require a 1-2 night stay in the hospital for monitoring. Patients will not know what they receive for the first two years, to prevent biased data collection. After that they will be unblinded and followed for an additional three years.
Eligibility Criteria
- Age 18 or older with moderate to severe symptoms of heart muscle disease Mild to moderate symptoms of mitral valve disease Able to walk between 165 to 500 yards in six minutes Taking heart failure medication for at least three months Absence of other implanted devices