Clinical trial NCT04353453: Study to Evaluate the Performance of CardiacSense PPG Sensor
Official title: A Prospective, Single-Center, Controlled Study to Evaluate the Performance of CardiacSense PPG Sensor in the CardiacSense1 Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Cardiology
Lead sponsor: CardiacSense Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: PPG individual peak detection
timeFrame: 90 Minutes
measure: PPG and Holter ECG signals correlation
timeFrame: 90 Minutes
Secondary outcomes:
measure: signal intensity under different conditions
timeFrame: 90 minutes
measure: Adverse events
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References: