Study to Evaluate the Performance of CardiacSense PPG Sensor

Not Applicable

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT04353453
• Lead Sponsor: CardiacSense Ltd.

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.

Study Timeline

• Study Start: 2018-02-19
• Primary Completion: 2019-03-18
• Study Completion: 2019-03-18
• Status Verified: 2020-04
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Last Update Submitted: 2020-04-16
• Study First Posted: 2020-04-20
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PPG and Holter ECG signals correlation	90 Minutes	Evaluation of the correlation between PPG signals and Holter ECG signals with respect to R-R signal intervals.
PPG individual peak detection	90 Minutes	Comparison of CardiacSense1 PPG individual peak detection to the corresponding recorded activity of an FDA-cleared ECG Holter, on a beat-by-beat basis.

Secondary Outcome Measures

Name	Time	Method
signal intensity under different conditions	90 minutes	Examination of PPG signal optic parameters (LED current, LED intensity) and signal intensity under different conditions.
Adverse events	90 minutes	Rate of Adverse events related or unrelated to the study device.

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel