Clinical Use of the SmartCardia Wireless Recorder as a Telemetry System in Patients Hospitalized Outside Intensive Care (the SMART-TEL Study Trial)

Cardiac arrhythmias, such as atrial fibrillation or ventricular arrhythmias, are often asymptomatic and sometimes associated with an adverse event, such as a stroke or syncope. Telemetry monitoring in hospitals, 24 hours a day, is the most used method for detecting these cardiac arrhythmias, especially after major surgery or cardiac surgery. Currently this cardiac monitoring is ensured by a system called telemetry, a kind of box connected to 4 electrodes stuck on the patient's chest. Information is continuously transmitted to a screen located in the nurses' room, which is supposed to watch the screen continuously. There are also alarms that can be triggered when an arrhythmia occurs. In practice, it is found that very often the electrodes are disconnected for practical reasons (patient going to the toilet for example) or accidentally. The alarms are not always observed because they very often sound badly. In addition, 24-hour telemetric monitoring sometimes fails to detect the culprit arrhythmia. Event monitoring significantly increases performance of the system. It has recently been shown that the ZIO patch (iRhythm Technologies Ltd.), a wireless electrocardiography allows te detection of arrhythmias in children, confirming the usefulness of such devices in daily practice.

3.2 Investigational product and indication.

The SmartCardia patch (SmartCardia, EPFL (Ecole polytechnique fédérale Lausanne) Innovation Park, Lausanne, Switzerland) is a lightweight wireless ECG device (Figure 1) mounted on a patch with waterproof properties. The device is completely wireless and has no external connection wires. It allows patients to go about their daily activities with minimal disruption. The SmartCardia system allows in hospital patients monitoring, and corresponds to telemetry, functioning as 24 hour cardiac monitoring. The device is placed on the upper left part of the patient's chest (Figure 2). The patch can wirelessly communicate the data to a screen that will display it live. In addition, this data will be stored in the recording device and in the cloud. Once monitoring is complete, the data remains stored in the cloud and is available to physicians. During the recording, at any time, the doctor can be connected and interrogate the device in order to visualise the arrhythmias of his patient. The first studies using this device in the clinic have recently been published with very encouraging results. The device is classified in category A (Swiss government office decision attached). Previous trials with this device have shown its clinical usefulness in the intensive care unit and in daily practice. The device is actually proposed and used by many cardiologists as an alternative to the conventional Holter monitoring system. The goal of the present trial is mainly to confirm tha ability of this device to be used as a telemetry system on the ward in order to overpass the inconvenience of the actual system related to permanent cable connections with the risk of disconnexion and lost of monitoring. This trial is mainly a confirmation of that the device is a valuable option for telemetry.

The device used for this trial is the one certified by Swissmedics with UE (Union Européenne) certification

3.3 Pre-clinical evidence