Remote Monitoring of Atrial High Rate Episodes in Pacemaker Patients. The Rapid Study Design.

Abstract

Remote Monitoring (RM) has been introduced for several years and nowadays most pacemakers are equipped with such a technology. RM can provide early detection of high atrial rate episodes (AHREs) onset and enable prompt medical intervention. However, there are still little data on the clinical reactions triggered by the AHRE detected by RM of pacemaker recipients and on their possible benefit on patients' outcome. The RAPID study is a multicenter, prospective, non-interventional study designed to compare the time from onset to first physician's evaluation of AHRE episode with arrhythmic burden ≥5% (72 minutes) for pacemaker recipients without atrial fibrillation history, between patients followed with RM or conventionally with annual in-hospital visits. A total of 98 patients with implanted dual-chamber pacemaker, assigned to RM-OFF or RM-ON according to ordinary clinical site practice, will be followed for a total of 18 months. After the implant, patients will perform their first in-hospital follow-up visit at 1 month and then, in the RM-OFF group, patients will perform an in-hospital FU every 6 months, while in the active group, patients will be continuously monitored via RM until study termination. All AHREs and consequent medical interventions will be collected over the entire study period. The ongoing RAPID study will provide additional information on the role of RM in the management of AHRE detected in pacemaker patients without documented atrial fibrillation history in ordinary clinical practice.