Clinical Data Validation of Novel Wireless Cortrium C3 Monitor for Continuous Electrocardiogram Measurements

Development of new cost effective mobile devices and wireless technology has great potential in supervision of critically ill patients in wards as well as ambulant. Through continuous wireless monitoring in both the hospital and the patients home, detection of heart arrhythmias such as atrial fibrillation (AF) will be possible.

AF is the cause of a sizeable amount of strokes (15% of all, and more than 35% of the population over 80 years of age), which can be prevented through anticoagulation treatment if provided in time. Thus, many patients are referred to cardiologic ambulatory to be examined for AF, and are subjected to heart monitoring with a so-called Holter or event monitor. This entails the patient be equipped with several electrodes on the chest, to which leads are attached and connected to a sizable and bulky box. The patient carries this box around hanging from the shoulder, belt or something similar for one or several days. It is then required of the patient to come back and deliver the device, after which the data must be read and analysed, in order to work out a further plan for the patient. During admission, a similar system can be attached for continuous heart monitoring.

Cortrium (http://cortrium.com) has developed a wireless technology, where a small C3 monitor is attached to the chest with standard electrodes and the leads are built into the actual monitor. The quality of the signal has been tested on healthy adults, but is yet to be tested on patients suffering from arrhythmias

The purpose of this study is to validate the quality of the ECG-signal acquired with the Cortrium C3 monitor. The intention is to evaluate whether the diagnosis of atrial fibrillation based on the ECG signal from the C3 monitor concurs with the current monitoring methods used in clinical practice.

The measurements are performed on patients under investigation for AF at cardiology ambulatory Y at Frederiksberg-Bispebjerg Hospital and Aleris-Hamlet Hospital, Copenhagen. The patients are outfitted with a C3 monitor simultaneous with the use of the conventional ambulatory apparatus. This is a "Holter monitor" (Rozinn station RZ152+12 and RZ153+ from ScottCare Holter for Windows 2010 (CE0120) and "EventCare SA version" (CE0120), both bought via SEMCA Ap, Skævinge, Denmark.