The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) study: rationale and design

Abstract

Background: With the advent of remote monitoring, current models of implantable cardioverter defibrillators (ICDs) have the possibility of sending automatic alert messages that allow early diagnosis of events such as lung fluid overload, atrial fibrillation and device integrity issues. Timely treatment of these events has the potential to improve patient outcome, but this has not as yet been proven.

Methods: The MORE-CARE study is a multicenter randomized controlled trial evaluating the efficacy of advanced device diagnostics and remote monitoring in improving the outcome of patients with biventricular ICDs. Up to 1720 patients with a standard indication for a biventricular ICD will be randomized to standard in-office follow-up, or to a remote monitoring strategy using the CareLink network and involving automatic alerts for lung fluid overload, atrial fibrillation, and device integrity issues. The first phase aims at evaluating the delay between an alert event, and clinical action to the event. The second phase of the study will evaluate whether the remote monitoring strategy results in a significant reduction of a combined end point of total mortality or cardiovascular and device-related hospitalization. The duration of the study will be event-driven due to its sequential design.

Conclusion: MORE-CARE will evaluate the efficacy of remote monitoring for improving patient outcome in patients implanted with a biventricular ICD.

Trial registration: ClinicalTrials.gov NCT00885677.