For Referrers: Refer your patients to the EMPOWER Trial

Why Refer Your Patients to the EMPOWER Trial?

The EMPOWER Trial evaluates the Carillon Mitral Contour System® vs. medical management as a first-line device option to treat many functional MR patients suffering from heart failure.

Today, earlier-stage FMR patients have no approved treatment when medication no longer manages their heart failure symptoms. These early stage FMR patients with MR grade I-II, as well as patients with MR grade III-IV, could benefit from an FDA-approved device therapy that is minimally-invasive and simple to implant that addresses FMR before damage becomes permanent.

Study Highlights

Studying patients with MR grades I-IV caused by enlarged left ventricle
Inclusive of patients with earlier-stage FMR
First U.S. randomized, blinded, sham-controlled mitral repair trial
Allows for alternative therapy within trial to avoid dropouts

Study Design & Primary Endpoints

Who is Eligible for the EMPOWER Trial?

Ischemic or non-ischemic dilated cardiomyopathy

Dilated mitral valve annulus

Functional (Secondary) Mitral Regurgitation (≥MR 1+) LV

EF ≤ 50%

LVEDD ≥ 60mm

LVESD ≤ 70 mm

Pre-existing device (e.g. pacing lead) in coronary sinus

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

About the Therapy – Carillon Mitral Contour System

View the Carillon procedure

Minimally invasive
Short procedure, often about one hour
Has been evaluated in several clinical studies, including a blinded randomized, controlled study, which demonstrated that the procedure had an excellent safety profile, and that patients implanted with the Carillon device and using medical therapy were more likely to have reduced mitral regurgitation and experience a reduction in heart size as compared to patients who were treated with medical therapy alone¹
Has received CE Mark in Europe and is included in the 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

Patient Resources

Share these trial resources with your interested patients

PATIENT BROCHURE

PATIENT WEBSITE

Show footnotes

Witte K, et al. A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation: The REDUCE FMR Trial. J Am Coll Cardiol HF. 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.

*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.