Study to Evaluate the Performance of CardiacSense PPG Sensor

CardiacSense

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Device: Study Procedure for Participants That Were Not in the Driving Group

Device: Study Procedure for Participants That Were Included in the Driving Group

Study type

Interventional

Funder types

Industry

Identifiers

NCT04353453

CL00201

Details and patient eligibility

About

study to evaluate the performance of the CardiacSense1's embedded PPG under different environmental and physical conditions

Full description

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.

Enrollment

24 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age of eighteen to eighty-five (18-85) years
Ability and willing to sign informed consent form
For subjects in groups other than Heart Arrhythmias- Self-declared not to be diagnosed with any arrhythmia
Compliance with hair, age, BMI skin and heart arrhythmia variables as defined above

Exclusion criteria

Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.
Subject with low perfusion indicated by the watch
Pregnant or breastfeeding woman (women of child-bearing potential must have a negative pregnancy test within screening period).