Evaluation of the performance of CardioSTAT for the detection of atrial and ventricular arrhythmia in pediatric patients


Palpitations are responsible for frequent consultation in pediatric cardiology and are a source of great anxiety for children and their parents. These arrhythmias can have functional consequences and in some cases can be dangerous. A precise and rapid diagnosis allows an effective and directed care.
Two non-invasive diagnostic tools are currently available but do not always provide an answer. CardioSTAT, already approved in adults, is a non-invasive diagnostic tool that allows continuous recording of 7 or 14 days of heart rhythm and rate.
The pilot phase of the study demonstrated that the quality of the CardioSTAT traces is similar to that obtained with a standard EKG recording device.
In phase 2, currently underway, we want to demonstrate the ability and superiority of CardioSTAT (14-day wearing) over the existing available tools, to detect arrhythmias in children or determine the rhythm during symptomatic episode. In addition, its quick installation and its small size make it a tool with additional potential for our young patients.
The anticipated benefits for improving the delivery of care and services are that this device will allow us to clarify the diagnosis in a higher percentage of patients, thereby reducing the time between the initial consultation and the medical management of the patient. Better or faster diagnosis could potentially decrease the need for invasive testing, decrease diagnostic costs, decrease stress, decrease the risks inherent in an invasive procedure.