On March 19th at 8:30 CET, the results of the prospective, double-blinded, international clinical trial WATCH AF will be revealed in the “Late-breaking Science – Innovation” session at the 2018 European Heart Rhythm Association (EHRA) congress in Barcelona.
The SmartWATCHes for Detection of Atrial Fibrillation trial conducted in Switzerland and Germany (ClinicalTrials.gov ID: NCT02956343) is the world’s first multicenter trial to evaluate the accuracy of a smartwatch in detecting AF with standard pulse sensor versus ECG based diagnosis by two cardiologists. The German technology innovator Preventicus provided the application for blinded analysis of photoplethysmographic (PPG) pulse signals, captured with a Samsung Gear Fit II smartwatch in 636 subjects.
The smartwatch application “Preventicus Nightwatch®” incorporates that algorithm. It can continuously 24/7 analyze PPG data recorded with smartwatches and document AF events lasting at least 1 minute. The application will be launched in Europe as a certified medical device.
The same algorithm is already available in a smartphone camera application (“Preventicus® Heartbeats”, a CE marked medical device). The results of the corresponding DETECT AF PRO trial (ClinicalTrials.gov ID: NCT02949180) are introduced in the same session.
How are AF events captured by smartwatches or smartphones accessible to Medical Professionals?
All detected AF events are accessible on a dedicated ICT platform, allowing medical professionals to oversee their patients using the new technology. The algorithm of the Preventicus® app analyses every single heartbeat recorded and classifies it as regular or irregular. The resulting report enables medical professionals to beat by beat comprehend the recorded events.
Why screening of AF with smart devices makes sense and why it helps to prevent strokes?
Stroke is the second most cause of death and is strongly associated with undetected or untreated AF – the most common sustained cardiac arrhythmia. AF may come and go and is often not noticed (silent AF). Its sporadic occurrence is the main reason why it is so difficult to capture. Chances to detect sporadic AF with „classic” methods (e.g. 24h-Holter-ECG) are around 25% only. It is estimated that every ten seconds a stroke happens in combination with unknown or untreated AF. Only when AF is detected and confirmed, e.g. pharmaceutical treatment can be started and stroke rate can be significantly reduced. This is why smartwatches and smartphone camera applications now aim to close a gap. They are considered as new AF screening tools in a recent EHRA consensus statement and make AF population screening – to prevent strokes – available to patients and medical professionals.
Read more about the clinical studies here.