For Patients: About the EMPOWER Trial

About the 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 address the underlying cause of FMR, as well as slow or stop the progression of your heart failure with the potential to improve your symptoms 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 has been associated with improved clinical outcomes, including potential survival benefit, reduced heart failure-related hospitalizations, and enhanced long-term quality of life.

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

Does not prevent continued standard-of-care therapies during trial participation
Control patients may receive the Carillon device post-unblinding. All patients will be unblinded at the earlier of 24 months or once the last patient in the trial reaches 12 months
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

I’m interested in participating

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., Canada 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 may 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.

Though investigational in the U.S., Carillon therapy has been evaluated in several safety studies outside the U.S., 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.^{1, 15, 18, 30}

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. and Canada.

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 existing or future heart failure treatment options – if required

Thousands of people have been treated with Carillon therapy worldwide

View the Carillon procedure

Find a Study Site

Click on to contact a center near you to see if you are eligible for the EMPOWER Trial

Am I a Candidate?

You may be a candidate for the EMPOWER Trial if you:

Have been diagnosed with heart failure and mild-to-severe FMR
Have symptoms of heart failure, such as difficulty walking up stairs, and require heart failure medications
Do not have another device placed in your coronary sinus. However, if you have a CRT device with a lead in your coronary sinus, you may still be eligible for the study. Please speak with your doctor
Have not been hospitalized due to heart failure in the past 30 days
Are not participating in another heart failure trial

If all of the above are generally applicable to you, you may be eligible to participate in the EMPOWER Trial

Why Should I Participate?

Although investigational, the Carillon therapy has the potential to help earlier in your disease state and is designed to provide benefits otherwise unavailable through commercially available therapies in the U.S.

Other notable aspects of the therapy and trial include:

A short, minimally invasive procedure
Designed with safety in mind – no required change in medications, no requirement for general anesthesia and no additional long-term blood thinners typically required as a result of the Carillon therapy
Control patients may receive the Carillon device post-unblinding. All patients will be unblinded at the earlier of 24 months or once the last patient in the trial reaches 12 months
The potential to be treated earlier in the course of your disease, before your disease substantially progresses and irreversible damage has been done
The Carillon implant is located outside, but next to, your mitral valve which keeps all future heart failure treatment options open
The opportunity to be part of research that may help other people with the same condition improve their lives

As with all investigational studies, the therapy may not benefit all participants and risks associated with the procedure and device will be discussed with your study doctor.

Learn more about the EMPOWER Trial – download the Study Brochure

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CAUTION: USA: Investigational device. Limited by Federal (or United States) law to investigational use.

Canada: Investigational device. To be used by qualified investigators only.

Cardiac Dimensions, Carillon, Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions Pty Ltd.

The Carillon Mitral Contour System is CE Marked (0344) and is commercially available in Europe and other countries.

CAUTION: USA: Investigational device. Limited by Federal (or United States) law to investigational use.

Canada: Investigational device. To be used by qualified investigators only.

Cardiac Dimensions, Carillon, Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions Pty Ltd.

The Carillon Mitral Contour System is CE Marked (0344) and is commercially available in Europe and other countries.