An interventional study of CS1 & heart monitor in Atrium; Fibrillation, sponsored by CardiacSense Ltd.. Completed at 2 sites in Israel. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-21.
Sponsored by CardiacSense Ltd. · Not applicable, Interventional, and Screening
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%.
Exclusion Criteria:
Males and females diagnosed with atrial fibrillation will be fitted with the CardiacSense1 and Holter heart monitor for 24-48 hours while going about daily activities, results shall be compared and analysed
Device: CS1 & heart monitor
Males and females not diagnosed with atrial fibrillation will be fitted with the CardiacSense1 and Holter heart monitor for 24-48 hours while going about daily activities, results shall be compared and analysed
Device: CS1 & heart monitor
Daily activities while wearing the investigational device as well as the control device
CardicacSense1 atrial fibrillation detection rate
Comparison of the number of atrial fibrillation sessions detected by reference comparing to PPG and ECG sensors in CardiacSense device.
Time frame: 24 to 48 hours
Safety of CardicacSense1
Incidence and severity of device related Adverse Events
Time frame: 24 to 48 hours
Usability
Ease of use of the CardiacSense1 device based on user questionnaire
Time frame: 24 to 48 hours
Plan to share: No — No individual data will be shared. Data analysis will include comparative overall data between investigational device and control device, as well as usability data
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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CardiacSense Ltd.