Medtronic Inc. has enrolled the first patients in MIRACLE EF, a global clinical trial to evaluate the effectiveness of Cardiac Resynchronization Therapy-Pacemakers (CRT-P). The technology can be used to delay the progression of heart failure in symptomatic patients with mild reduced heart pumping function.
This large study will be the first to evaluate CRT-P in a widely underserved patient group. The group consists of patients that have a slightly reduced Left Ventricular Ejection Fraction (LVEF) in the range of 36 to 50 percent. This means that the hearts work somewhat more efficiently than heart failure patients who are currently indicated for implanted device therapy because of their lower LVEF.
Approximately 275 centers throughout the world in regions including the U.S. Canada, Europe, Japan plus developing markets will enroll up to 2.300 patients who will receive a Medtronic Consulta® CRT-P in this prospective, double-blind randomized controlled trial. Patients will be followed for at least two years or until the close of the study. Medtronic anticipates the trial will take four to five years to complete. The CRT-P devices used in Miracle EF are not approved by the FDA for the patient population being studied.
In addition, Yale University is working in partnership with Medtronic University through a five year cooperative agreement established by the FDA to develop enhanced methods to evaluate the safety of medical devices.
The partners will develop a general framework for key methodologies, best practices, and strategies that are essential for the development of an effective U.S. medical device surveillance registry network.
“There is a great need to develop methods and initiatives to ensure that the devices that are approved are truly safe and effective when they are adopted into practice,” said Harlan Krumholz, M.D., Professor of Medicine and Director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation. “We need systems that provide early warnings if there are problems and provide the information needed to ensure that these devices are providing the benefits that we expect,” Krumholz added.
For more information, go to www.medtronic.com.