EMPOWER Trial

The EMPOWER Trial is studying the investigational* Carillon Mitral Contour System^® – a minimally invasive therapy designed to treat people with heart failure and any amount of functional mitral regurgitation (commonly known as FMR – a form of mitral valve leakage). The Carillon therapy is intended to not only address the underlying cause of FMR, but also the progression of your heart failure with the potential to improve your survival and quality of life. The EMPOWER Trial is evaluating the ability of the Carillon therapy to do two things:

• Help people feel better in the near-term by improving their FMR
• Help people feel better for the long term by reducing the size of the left ventricle of their heart – called favorable remodeling – to help the heart function better. Favorable remodeling is associated with improved survival, reduced heart failure-related hospitalizations, and enhanced long-term quality of life.^1,2,3

Of interest, this is the first randomized, blinded, sham-controlled mitral repair clinical trial in the U.S. The EMPOWER Trial is also unique in that it that has the following aspects:

• Allows for alternative therapies within the trial, so none of your therapeutic options are sacrificed for trial participation
• At the end of the initial 24-month study period, people in the control group that did not receive Carillon therapy may be eligible to be treated at that time
• The trial is evaluating treatment as an early disease intervention for MR grade I-II, in addition to treating later stage patients with MR grade III-IV

The EMPOWER Trial will be enrolling up to 300 people with heart failure and mild-to-severe FMR (MR grade I-IV) in the U.S. and Europe to assess outcomes.

Study Rationale:

When the mitral valve does not close tightly, causing it to leak, this condition is called mitral regurgitation. Although there are different types of mitral regurgitation, the Carillon therapy is designed to treat functional mitral regurgitation (FMR), also known as secondary mitral regurgitation (SMR). This means that the valve leakage is caused by another condition and is secondary to the original cause. FMR develops as a result of things such as a heart attack or coronary artery disease, where the damaged portion of the heart is no longer able to function properly. This causes the healthy part of the heart to work harder to pump the same amount of blood, enlarging the heart and resulting in heart failure. The enlarged portion of the heart, typically the left ventricle, exerts pressure on the mitral valve, causing it to stretch and preventing it from closing completely, which in turn causes blood to flow backward through the mitral valve. FMR can be compared to a door frame being too big for the doors, resulting in gaps and an incomplete seal.  

                                                                      
Heart failure medication typically helps address FMR symptoms for people with heart failure but may not impact the structural root cause of the disease, which is the enlarged left ventricle. An enlarged ventricle is associated with increased mortality (death), heart failure-related hospitalizations, and a poor long-term quality of life. Device options currently approved by the Food and Drug Administration (FDA) are fairly restrictive, only intended for individuals with moderate-to-severe mitral regurgitation (MR grade III-IV) and do not address the root cause of the FMR.

Signs & Symptoms of FMR:

• Shortness of breath or cough
• Fatigue (feeling tired and worn out)
• Abnormal sounds of the heart heard through a stethoscope
• Heart palpitations or fluttering heartbeat
• Swollen feet or ankles
• Lightheadedness

What is Being Studied? 

The investigational Carillon Mitral Contour System is a minimally invasive therapy – i.e., not a surgical approach. The permanent, investigational Carillon device is placed using a nonsurgical, catheter-based technique in the coronary sinus, a vein on the outside of the heart that is next to the mitral valve. During the procedure, the Carillon device is cinched around the mitral valve. This is designed to do two things: reduce your mitral valve leak, and ultimately, reduce the size of your enlarged left ventricle. This approach is different from any other available treatment and it is intended to both improve your heart failure symptoms as well as the function of your heart over time. The implant procedure usually takes about an hour and is performed in a catheterization lab.

The investigational Carillon therapy has been evaluated in several safety studies, including a blinded, randomized, sham-controlled study, that demonstrated that patients treated with Carillon therapy and heart failure medications may be more likely to have reduced mitral valve leakage and a reduction in left ventricle size than people on standard medical therapy alone.⁴ Carillon therapy has been commercially available in Europe since 2012 and has been used to treat thousands of people worldwide. However, it is an investigational device in the U.S.

In the Carillon procedure:

• No general anesthesia is required
• No additional or changes in medications are needed as a result of the Carillon therapy
• The Carillon device does not interfere with future heart failure treatment options – if required

Thousands of people have been treated with Carillon therapy worldwide