Atrium; Fibrillation Clinical Trial
Official title:
A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
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
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%.
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