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.1,2,3
Today, patients that no longer respond to medication must wait until their FMR is 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 to improve survival, reduce heart failure hospitalizations, and enhance long-term quality of life
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.
- Enrolling heart failure patients with any FMR (MR grade I-IV)
- First U.S. randomized, blinded, sham-controlled mitral repair trial
- 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
- Allows use of alternative therapies to treat participants within trial so no options are sacrificed during their participation in the trial
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)
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 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 – does not require any change in patient medications, general anesthesia, or blood thinner regimen as a result of Carillon therapy
- Carillon therapy has been evaluated in several safety studies and a blinded, randomized, sham-controlled study that demonstrated that people treated with Carillon therapy and heart failure medications were more likely to have reduced mitral valve leakage and a reduction in left ventricle size than people taking medication alone4
- Has CE Mark in Europe and is included in European Society of Cardiology (ESC) guidelines covering the diagnosis and treatment of acute and chronic heart failure for the treatment of secondary mitral regurgitation
- Thousands of patients treated worldwide
I’d like more information on the EMPOWER Trial for my patients
Share these trial resources with your interested patients
- Kramer DG, Trikalinos TA, Kent DM, Antonopoulos GV, Konstam MA, Udelson JE. Quantitative evaluation of drug or device effects on ventricular remodeling as predictors of therapeutic effects on mortality in patients with heart failure and reduced ejection fraction: a Meta-Analytic approach. J Am Coll Cardiol. 2010;56(5):392–406.
- Yu C, Bleeker GB, Fung JW, Schallj MJ, Zhang Q, van der Wall EE, Chan Y, Kong S, Bax JJ. Left Ventricular Reverse Remodeling but Not Clinical Improvement Predicts Long-Term Survival After Cardiac Resynchronization Therapy. Circulation. 2005;112(11):1580-1586
- Aimo A, Gaggin HK, Barison A, Emdin M, Januzzi Jr JL. Imaging, Biomarker, and Clinical Predictors of Cardiac Remodeling in Heart Failure with Reduced Ejection Fraction. JACC: Heart Failure. 2019;7(9):782-794.
- Witte K, et al. A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation: The REDUCE FMR Trial. JACC: Heart Failure. DOI: 10.1016/j.jchf.2019.06.011
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NOTE: The Carillon Mitral Contour System has received CE Mark (0344) and is available for sale in Europe and other countries that recognize CE Mark.
CAUTION: Investigational Device. Limited by United States law to investigational use.