Atrial Fibrillation Clinical Trial
Official title:
A Prospective, Single-Center, Controlled Study to Evaluate the Performance of CardiacSense PPG Sensor in the CardiacSense1 Device
study to evaluate the performance of the CardiacSense1's embedded PPG under different environmental and physical conditions
The clinical study is a Prospective, Open, Single-Center, and Controlled Study to Evaluate
the Performance of a PPG sensor in the CardiacSense1 device.
The CardiacSense1 is a wrist worn device designed to detect atrial fibrillation (AF). The AF
detection of the device is based on a portable photoplethysmograph (PPG) sensor that is
designed for continuous heart rate monitoring. The photoplethysmograph is a noninvasive
circulatory signal related to the pulsatile volume of blood in the tissue.
Twenty (20) subjects (female and male) that do not suffer from atrial defibrillation and
additional four (4) patients who are diagnosed as suffering from atrial fibrillation will be
enrolled to the study.
Comparison of CardiacSense1 PPG individual peak detection to the corresponding recorded
activity of an FDA-cleared ECG Holter, on a beat-by-beat basis will be performed on the
following conditions:
All subjects will be exposed to 45 minutes of indoor standard office fluorescent light and 45
minutes to outdoor sunlight during mid-day. In addition, Subjects will be asked to walk for 1
minute once every 10 minutes and will be exposed to an indoor environment of 22±3 - 28±3
degree Celsius for 45 minutes and outdoor temperature of at least 15 degree Celsius, on the
other 45 minutes.
4 Subjects will be tested in the following conditions: driving a car for 30 minutes; High
wrist hair density subjects; Two subjects 65 y/o or older, two subjects 30 y/o or younger;
Two subjects with BMI below 18.5 (underweight) and two subjects with BMI over 30 (Obesity);
Two subjects with skin type 6 (Fitzpatrick) and two subjects with skin type 5; Four subjects
with diagnosed persistent atrial fibrillation.
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