About the EMPOWER Trial
Studying a minimally-invasive option designed to treat functional mitral regurgitation (FMR) before the disease progresses and damage becomes permanent – Treats patients with MR grades I-IV
Determining the ability of the Carillon Mitral Contour System® to:
- Reduce mitral valve leakage
- Enable the heart to function better
- Help patients feel better and resume their active lives
Study allows patients to receive alternative therapies within the study parameters should they need them or should their disease progress
Enrolling up to 300 patients in the U.S. and Europe
First randomized, blinded, sham-controlled mitral repair clinical trial in the U.S.
When the mitral valve does not close tightly and leaks, this is called mitral regurgitation.
There are different types of mitral regurgitation. The therapy being studied in this clinical study is designed to treat functional mitral regurgitation (FMR), also known as secondary mitral regurgitation (SMR) – meaning that the valve leakage is caused by another condition and is secondary to the original cause.
Functional mitral regurgitation is a disease of the heart, where part of the heart has been damaged by a heart attack or coronary artery disease and that part is no longer able to function. This causes the healthy part of the heart to work harder to pump the same amount of blood, enlarging the heart, which presses on the mitral valve and stretches it out. The misshapen mitral valve is unable to close completely and allows blood to leak. FMR is similar to a door frame being the wrong size for the door – gaps are created where cold air will leak in or warm air will leak out of a room.
Signs & Symptoms of FMR
What is Being Studied?
The Carillon Mitral Contour System is a minimally-invasive implant designed to cinch the mitral valve, bringing it back to a normal shape so the leaflets can close properly. This is intended to reduce the leakage of your mitral valve, which may normalize the size of your heart (called remodeling) and its function.
The Carillon® device has been evaluated in several prior clinical studies, including a blinded, randomized, controlled study, which demonstrated 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 alone.1
Thousands of patients have been treated with the Carillon device worldwide
View the Carillon procedure
U.S. Study Locations
Am I a Candidate?
You may be a candidate for the EMPOWER Trial if you:
- Have been diagnosed with heart failure and functional mitral regurgitation (FMR)
- Have symptoms of heart failure, such as difficulty walking upstairs or require heart failure medications like diuretics
- Do not have another device located in your coronary sinus; some types of pacemakers, called CRT, are implanted in the coronary sinus and would prevent access or deployment of the Carillon device
- Have not been hospitalized due to heart failure in the past 30 days
- Are not participating in another heart failure trial
Why Should I Participate?
- Minimally invasive therapy
- Short procedure
- Potential to be treated earlier in the course of your disease, before your disease substantially progresses and irreversible damage has been done
- Ability to receive alternative therapies within the study parameters should you need them or should your disease progress
- Opportunity to be part of research that may help other people with the same condition improve their lives
Learn more about the EMPOWER Trial
I’d like more information on the EMPOWER Trial
- 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.