The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib). Study design as as follows:~100 subjects, 50 (at least 30% of each gender) with A-fib and 50 without (at least 30% of each gender).~All subjects will be measured during at least 24 hours. Primary endpoint - A-Fib detection Control: Holter device will be the reference~For PPG analysis, each one hour will be considered as an event:~If A-Fib is present for more than accumulated 5 minutes in that specific hour then it shall be considered an A-Fib hour If A-fib was present for less than accumulated 5 minutes then it shall be considered a Non-A-Fib hour.~For ECG analysis, each measurement of between 1-3 minutes will be considered an event.~If A-Fib is present at that specific measurement, then it shall be considered an A-Fib event If A-fib was not present at that specific measurement, then it shall be considered a Non-A-Fib hour.~Sensitivity (true positive) is defined as the percentage of Holter defined A-fib hours/A-Fib event found by PPG/ECG.~The asked sensitivity is 90%. Specificity (true negative) is defined as the percentage of Holter defined Non-A-fib hours/A-Fib event found by PPG/ECG. The required specificity is 90%.
A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation.~The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib) based on a comparison to a control device, which is an off-the-shelf cleared Holter ECG device