Atrium; Fibrillation
Conditions
Brief summary
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
Detailed description
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%.
Interventions
DEVICECS1 & heart monitor
Daily activities while wearing the investigational device as well as the control device
Sponsors
CardiacSense Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Males and females, 50 of them diagnosed with atrial fibrillation (AF), and 50 healthy participants, at least 30% of each gender in each group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Age of eighteen (18) year and above * Diagnosed with atrial fibrilation (Permanent of persistent), or healthy participants able to and willing to sign the informed consent form For control group-no known cardiac problems
Exclusion criteria
* Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study. * Subjects with low perfusion as indicated by the watch * Women who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CardicacSense1 atrial fibrillation detection rate | 24 to 48 hours | Comparison of the number of atrial fibrillation sessions detected by reference comparing to PPG and ECG sensors in CardiacSense device. |
| Safety of CardicacSense1 | 24 to 48 hours | Incidence and severity of device related Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability | 24 to 48 hours | Ease of use of the CardiacSense1 device based on user questionnaire |
Countries
Israel
Outcome results
None listed