SmartCardia Wireless Recorder as a Telemetry System
Condition: Arrhythmias, Cardiac; Monitoring
MeSH terms: Arrhythmias, Cardiac
Study type: Observational

Summary: 
      Patients hospitalized at the clinic Cecil who need telemetry will be monitored for 48 hours
      with the SmartCardia system in addition to conventional monitoring.
    

Detailed description: 
      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

      The benefits of using such a type of monitoring are obvious. The patient is autonomous in his
      movements. The risks associated with disconnection are nonexistent. In addition, the doctor
      can consult the patient's data directly at any time. Finally, the data are stored in the
      cloud and archiving is made easier. The only risk associated with this system is an allergy
      to the adhesive patch. In view of the potential benefits expected from the use of this
      system, it is easy to understand that the study is justified. It should be kept in mind that
      the conventional system also has limits essentially linked to the risk of cable
      disconnection.

      The risk linked to a bad registration of the SmartCardia system which would generate an
      incorrect treatment does not exist, because the clinical decision will be taken by the doctor
      and based only on the data provided by conventional monitoring.

      Previous trials have shown the accuracy and advantages of this new wireless recorder. The
      system is already used in the daily practice in several countries as an alternative to
      conventional Holter monitoring.

      3.4 Explanation for choice of comparator

      The new system will be used in parallel with the conventional monitoring system. It is
      obvious that the conventional monitoring system should be used as the gold standard.

      3.5 Risks/Benefit

      There are no risks related to the use of this new device as therapeutic decision will be
      based only the recording of the conventional system. Benefits could be expected in the future
      since wireless system are preferred by the patients as demonstrated in previous trials
      comparing Holter monitoring and the SmartCardia device.

      3.6 Justification of choice of study population

      Patients after cardiac surgery are usually monitored for a few days when they are back to the
      ward. It is obvious that they are the cohort of choice for such monitoring since they require
      it anyway.
    

Intervention name(s): Cardiac monitoring with the wireless device "SmartCardia"
Intervention type(s): Device
Intervention description(s): Monitoring of arrhythmia with a wireless device (SmartCardia)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients requiring cardiac monitoring after heart surgery will be included
      
Keywords: non invasive monitoring