June 23, 2009 - Today, Medtronic Inc. announced the first worldwide enrollments in the MORE-CARE (Monitoring Resynchronization in Cardiac Patients) trial, which will compare two disease management strategies for heart failure patients treated with an implantable device for cardiac resynchronization therapy. MORE-CARE aims to demonstrate that remote monitoring of these patients via the Medtronic CareLink Network is superior to in-office visits alone in terms of clinical effectiveness and healthcare system utilization.
The trial will utilize Medtronic wireless cardiac resynchronization therapy-defibrillators (CRT-Ds) equipped with OptiVol Fluid Status Monitoring and Medtronic CareAlert Notifications. The devices automatically notify a physician with a text message (SMS), e-mail or a Medtronic CareLink Web site message when certain pre-programmed thresholds are crossed without an in-office diagnosis by the physician. OptiVol CareAlert notifications are not available in the U.S., and no U.S. patients will be enrolled in this trial.
Principal investigators for the MORE-CARE trial are Dr. Haran Burri of University Hospital in Geneva, Switzerland; Dr. Aurelio Quesada of General University Hospital in Valencia, Spain; Professor Massimo Santini and Dr. Renato P. Ricci, both of S. Filippo Neri Hospital in Rome.
Enrolling up to 1,700 patients at approximately 80 centers worldwide, the MORE-CARE trial is a prospective, randomized, controlled trial with an expected duration of approximately four years. One set of patients will have CareAlert notifications activated for fluid accumulation in the chest area (captured via OptiVol measurements), AT/AF episodes and system integrity issues. The other group of patients will have audible alerts enabled for system integrity issues.
The trial is comprised of two phases. The first is a short-term evaluation of whether remote patient monitoring with Medtronic CRT-Ds and usage of the CareLink Network reduces the time from device-detected event onset to clinical decisions for arrhythmias, cardiovascular disease progression and system issues as compared to patients receiving only in-office care.
The second phase is a long-term evaluation. It aims to demonstrate that the remote monitoring strategy reduces the occurrence of major cardiovascular events since it allows for better follow-up heart failure disease progression.
OptiVol is found on Medtronic’s latest wireless defibrillators (Consulta and Concerto CRT-Ds, Secura and Virtuoso implantable cardioverter-defibrillators, or ICDs), and has been available on Medtronic devices since FDA approval in 2004. OptiVol fluid status monitoring uses low-level electrical pulses that travel across the thoracic cavity to measure the level of resistance. OptiVol’s ability to measure fluid status trends over time, in conjunction with other key device trends and physiologic measures available in Medtronic’s proprietary Cardiac Compass Reports, can provide the opportunity to intervene before patient symptoms develop.
As of Jan. 1, 2009, the U.S. Centers for Medicare and Medicaid Services have begun reimbursing physicians for their time spent monitoring heart failure patients using fluid trend data obtained from Medtronic implantable cardiac devices via CareLink Network remote transmission.
For more information: www.medtronic.com