For Referrers: Refer your patients to the EMPOWER Trial

Why Refer Your Patients to the EMPOWER Trial?

Guideline Directed Medical Therapy (GDMT) typically helps address symptoms for heart failure patients with functional mitral regurgitation but does not impact the root cause of the disease – an enlarged left ventricle. An enlarged ventricle is tied to an increase in mortality and heart failure-related hospitalizations, and poor long-term quality of life.

Today, patients whose symptoms progress despite medication are generally treated only once their FMR becomes advanced – MR grade III-IV – to be a candidate for devices to address their condition. There is a need for a therapy that treats FMR for both early and late stage patients, while also remodeling the left ventricle to impact the root cause of the disease.

The EMPOWER Trial is evaluating the ability of the Carillon Mitral Contour System^® to do two things for heart failure patients with FMR (MR grade I-IV):

Acute MR reduction to help patients feel better in the near term
Longer-term remodeling of the left ventricle with the potential to improve clinical outcomes, including heart failure hospitalizations, quality of life, and survival

Within the broader trial, the Carillon^® therapy is being evaluated as an early intervention to treat patients with heart failure and FMR (MR grade I-II) with a minimally invasive therapy before the disease progresses and the damage becomes irreversible.

I’d like information on how to enroll my patients

Study Highlights

Enrolling heart failure patients with any FMR (MR grade I-IV)
First U.S. randomized, blinded, sham-controlled mitral repair trial
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.
Allows use of alternative therapies during trial participation so no future treatment options are sacrificed

Study Design & Primary Endpoints

Who is Eligible for the EMPOWER Trial?

Generally, heart failure patients with a large left ventricle and any FMR (MR grade I-IV)

Functional mitral regurgitation (≥ MR 1+)

Cardiomyopathy (ischemic or non-ischemic)

LVEF ≤ 50%

LVEDD of ≥ 55mm for women and 57mm for men

Key exclusion criteria include

Presence of artificial mitral valve or leaflet repair device

HCM, RCM, infiltrative cardiomyopathy or CP

Degenerative mitral regurgitation

Severe tricuspid regurgitation

Severe aortic stenosis

Find a Study Site

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

About the Therapy – Carillon Mitral Contour System

View the Carillon procedure

Uniquely designed to reduce MR and favorably remodel the left ventricle
Short, minimally invasive procedure (often one hour or less)
Placed in a vein located next to the mitral valve (coronary sinus) to cinch the valve
Location of the device outside of the mitral valve keeps all future heart failure treatment options open
Designed with safety in mind – typically does not require changes in patient medications, general anesthesia, or long-term blood thinner therapy specifically as a result of Carillon therapy
Carillon therapy has been evaluated in several safety studies and has over 500 patients studied or part of registries worldwide. Carillon therapy also has the only randomized, blinded, sham controlled study for a mitral device completed. ^{1, 15, 18, 30}
The 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.
Has short- and long-term study and registry data showing both mechanical (i.e., MR reduction and left ventricular favorable remodeling) and clinical benefits (i.e., improvements in 6-minute walk distance, KCCQ, and NYHA class) to patients ^{1, 15, 18, 30}

As with all investigational therapies, risks associated with the procedure and device should be considered and discussed with eligible patients.

Learn more about Carillon therapy

I’d like more information on the EMPOWER Trial for my patients

Patient Resources

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Patient Brochures

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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.