EMPOWER
Carilion is one of the nearly 100 healthcare institutions worldwide participating in the EMPOWER study, which evaluates the safety and effectiveness of a new medical device for the treatment of mitral regurgitation in patients with heart failure.
About This Study
Summary
Sometimes after a heart attack or due to heart disease, the heart becomes enlarged. This stretching pulls the ring-shaped mitral valve out of shape, preventing it from closing fully and leading to leakage (regurgitation). Mitral regurgitation is the most common form of heart valve disease in the U.S. and worldwide. When the mitral valve doesn’t close fully, the heart must work harder to pump enough blood to the body.
The EMPOWER study examines whether a device that reshapes the mitral valve is safe and effective in people with heart failure and functional mitral regurgitation. Patients interested in participating in EMPOWER will have several heart imaging tests to see whether their heart is a good match for the study. Participants whose heart meets the study requirements will be assigned randomly (50:50, like a coin toss) to undergo the study procedure or will experience all parts of the procedure EXCEPT for device placement. Neither the lead scientist nor the participant can choose which procedure they’ll receive.
After leaving the hospital, participants can expect to have follow-up visits with their heart doctors and research team members at 1, 6, 12, 18, and 24 months. After 2 years, patients will be told which procedure they received. Then, all participants will be checked once a year for 3 more years, for a total of 5 years.
To be included in EMPOWER, participants must be / have
- Adult (18 years and older)
- Symptomatic heart failure, with functional mitral regurgitation
- Six-minute walk distance of 100 to 600 meters
- Left ventricular ejection fraction of 50% or less
To be included in EMPOWER, participants must not be / have
- Presence of a mechanical or bioprosthetic mitral valve or mitral valve annuloplasty or mitral leaflet repair device
- Significant mitral valve pathology, including rheumatic disease and partial or full chordal rupture
- Severe tricuspid valve regurgitation
- Severe aortic stenosis
- Chronic, severe medical conditions, or pathology other than heart failure
Keywords
Heart valve disease; Mitral insufficiency; Mitral regurgitation
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Jason Foerst, MD, is the medical director of the Structural Heart and Valve Center at Carilion Clinic, assistant professor of medicine at Virginia Tech Carilion School of Medicine, and director of Carilion's structural heart disease fellowship program. Dr. Foerst is a structural interventional cardiologist and researcher who completed his internship, residency, and fellowship training at Dartmouth–Hitchcock/Mary Hitchcock Memorial Hospital.
Official title of study
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR
Funding mechanism
Industry sponsored by Cardiac Dimensions, Inc.