Validation of a mobile bedside ECG Screening Tool for Arrhythmias in primary care practice

Patients frequently present to the family physician's office with symptoms as
the result of a cardiac arrhythmia. These arrhyhmias are frequently benign,
such as incidental extra atrial or ventricular beats but may also include
arrhythmias that warrant further work-up. Pulse examination and cardiac
auscultation are directly available screening tools for a family physicians.
When a cardiac arrhythmia is suspected, a 12-lead electrocardiogram (ECG) is
performed. In addition to symptomatic patients, family physicians are also
encouraged to do proactive case finding in patients who are at-risk for atrial
fibrillation which is associated with a 5-fold increase in risk for stroke.
Unfortunately obtaining a standard 12-lead ECG can be cumbersome, particularly
during house visits, and is not available in every family practice. The use of
a non-obtrusive smartphone-based single-lead ECG device ("Livv Mobiel ECG",
Livv Mobiel Health B.V., Zwolle, Netherlands) may lower this logistical
threshold and may therefore improve gain in diagnostic screening. In
symptomatic patients it may serve as immediate reassurance when an arrhythmia
is not found during symptoms, while allowing direct action in case an
arrhythmia is detected.

To validate the use of the Livv Mobiel ECG as a reliable office/bedside
screening tool in primary care practice

Patients who are subjected to undergo a standard 12-lead ECG at one of the
participating family practices will be consented to the VESTA study. Study
participants are asked to hold a small metal device for 30 seconds which remits
the ECG signal to a dedicated data-secure smartphone. This recording will be
stored and digitally sent to the investigators together with the standard
12-lead ECG for reference. The ECG recordings will be de-identified, shuffled
and sent out to two cardiologists for independent review. The cardiologists
record their findings in a secure electronic data capturing system (CastorEDC).
In case of disagreement, a third cardiologist will be consulted by the
investigators. Relevant medical information will be obtained from the
electronic medical records from each participating center and entered in an
online electronic data capturing system. At study completion, a short survey
will be sent to all participating nurses and primary care physicians regarding
device utility satisfaction.

A 30-second single-lead ECG registration by holding a small metal device that
is connected to a secure smartphone ("Livv Mobiel ECG", Livv Mobile Health
B.V., Zwolle, Netherlands). The investigational device is provided by the
company.

The nature of burden consists of holding a small metal ECG-signal detection
device for 30 seconds. Although every possible effort is undertaken to
guarantee patient safety, the risk of participation in this study (like any
other study) may include a data "leak" of collected data.