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 state-of-of-the-art Medtronic wireless cardiac resynchronization therapy-defibrillators (CRT-Ds) equipped with OptiVol fluid status monitoring and Medtronic CareAlert Notifications, which are designed to give automatic notification to a physician via text message (SMS), email or a Medtronic CareLink Web site message when certain pre-programmed thresholds are crossed (for example, OptiVol fluid levels or atrial fibrillation burden), without the physician having to see the patient in-office for diagnosis. OptiVol CareAlert notifications are not available in the US; further, no US 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; Prof. Massimo Santini and Dr. Renato P. Ricci, both of S. Filippo Neri Hospital in Rome.
First enrollments recently took place under the direction of Dr. Burri. “The MORE-CARE trial will assess the efficacy of remote monitoring to enable earlier detection of clinical events, and allow physicians to make appropriate treatment decisions based on patient and device data,” he said.
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 in the study will have CareAlert™ Notifications activated for fluid accumulation in the chest area (captured via OptiVol measurements), AT/AF (atrial tachycardia / atrial fibrillation, or irregular heart rhythm) 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:
• Short-term evaluation of whether remote patient monitoring of patients with Medtronic CRT-Ds and using the CareLink Network reduces the time from device-detected event onset to clinical decisions for arrhythmias, cardiovascular disease progression and system issues compared to patients receiving only in-office care; and
• Long-term evaluation, which aims to demonstrate that the remote monitoring strategy reduces the occurrence of major cardiovascular events since it allows for better follow-up on heart failure disease progression.
“Medtronic has played a pioneering role in remotely monitoring patients with implanted cardiac devices, and our imprint on improved heart failure treatment through our support of numerous clinical trials is unmatched,” said Marshall Stanton, M.D., vice president of clinical research for the Cardiac Rhythm Disease Management business at Medtronic. “MORE-CARE is the latest in a long history of Medtronic clinical trials that aims to bring better care to heart failure patients.”