FDA Guidance Allows Use of KardiaMobile 6L to Measure QTc in COVID-19 Patients

The KardiaMobile 6L – the world’s only six-lead personal ECG – is now cleared for use in the measurement of a patient’s QTc and detection of potentially dangerous QT prolongation.

A prolonged QTc can lead to a potentially fatal side effect, called drug-induced sudden cardiac death (DI-SCD) linked with the use of several medicines now being used in the treatment of COVID-19.

The QTc is a heart rate corrected interval that reflects the integrity of the heart’s electrical recharging system. Abnormal prolongation of the QTc can stem from congenital long QT syndrome, many disease states, electrolyte abnormalities, and over 100 FDA-approved medications that have the potential for unwanted QT prolongation.

Patients with a prolonged QTc are at greater risk of their hearts going into a potentially dangerous arrhythmia called Torsades de Pointes which can lead to sudden cardiac arrest and even worse, sudden cardia death.

With the global pandemic of COVID-19, several drugs being used off-label to treat COVID-19 which have the potential for unwanted QT prolongation and worse, DI-SCD.

With the KardiaMobile 6L a patient’s QTc can be obtained without exposing clinical staff to affected patients which helps to conserve personal protection equipment (PPE) and thereby expand the capacity of strained medical resources.

Healthcare professionals can now use KardiaMobile 6L to collect a six-lead ECG (Lead I, II, III, aVR, aVL, aV), and then use manual tools to calculate QT duration allowing them to make assessments with respect to patient medication.

Author: Andrew Webb

I am the Managing Director of PMS (Instruments) Ltd a successful UK based medical distribution, service and sales company specialising in cardiovascular equipment.