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

26.03.2020 10:45

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

World's only FDA-cleared six-lead personal ECG will be used by healthcare professionals to monitor QT duration in patients receiving medications that can cause potentially life threatening QT prolongation.

 

AliveCor, the leader in artificial intelligence (AI)-based, personal ECG technology, and provider of enterprise cardiology solutions, today announced that its KardiaMobile 6L – the world's only six-lead personal ECG – is now allowed 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), associated 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 for their hearts to go into a potentially dangerous arrhythmia called Torsades de Pointes which can lead to sudden cardiac arrest and even worse, SCD. With the global pandemic of COVID-19 upon us, several drugs being used off-label to treat COVID-19 include Hydroxychloroquine and Azithromycin, have the potential for unwanted QT prolongation and worse, DI-SCD.

"At AliveCor, we are committed to providing life-saving cardiological services to those who need them most. The benefits of remote, personal ECG measurement have never been clearer," said AliveCor CEO Priya Abani. "We are thankful to the FDA for issuing timely guidance to help expand the availability of our device to assist in the treatment of COVID-19 during this global health emergency."

"AliveCor's KardiaMobile 6L technology can play a key role in obtaining the patient's QTc as a vital sign to help guide the rapid and safe use of these drugs," said Michael J. Ackerman  M.D., Ph.D., genetic cardiologist and director of Mayo Clinic's Windland Smith Rice Genetic Heart Rhythm Clinic and Sudden Death Genomics Laboratory.  "In addition, the patient's QTc can be obtained without exposing ECG technicians to affected patients which helps to conserve personal protection equipment (PPE) and thereby expand the capacity of our strained medical resources.  We are encouraged by the progress being made by regulatory authorities in allowing us to rapidly respond to the COVID crisis." Beginning in 2017, AliveCor and Mayo Clinic have collaborated to develop advanced QT measurement technology.

With growing numbers of coronavirus cases worldwide and billions of people trying to fight off infection, the immediate availability of a device that can measure the potential life-threatening effects of medications prescribed to treat COVID-19 has never been more critical. Healthcare professionals will now be able to use KardiaMobile 6L to collect a six-lead ECG (Lead I, II, III, aVR, aVL, aV), use manual tools to calculate QT duration, and then make assessments with respect to patient medication. The KardiaMobile 6L is the only personal ECG to provide data from Lead II, which is simply unavailable from smart watch-based ECGs and is critical for the detection and monitoring for potentially life-threatening QT prolongation. This gives doctors, nurses, and other medical professionals the power to monitor QTc in patients receiving what will hopefully be life-saving treatment for COVID-19, whether in the hospital, or at-home.

The study is available here

AliveCor expects to soon add a professional QTc monitoring service which will facilitate a more seamless workflow with no on-premise calculations required. The Kardia Mobile 6L is sold in Germany, Austria and Switzerland at www.mindtecstore.com. There are special offers and volume discounts for hospitals and healthcare providers available. Approval is currently available for the USA, we hope that it will soon be granted in the EU.

AliveCor's products are available here.