Study to Evaluate the Performance of CardiacSense PPG Sensor

NACompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 19, 2018

Primary Completion Date

March 18, 2019

Study Completion Date

March 18, 2019

Conditions
Atrial Fibrillation
Interventions
DEVICE

Study Procedure for Participants That Were Not in the Driving Group

"Subjects were fitted with One lead Holter monitor and the CardiacSense1 watch simultaneously and were tested in the following condition:~1. Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 28 ±3 degree Celsius.~2. Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 22 ±3 degree Celsius.~3. Sitting down for 10 minutes,outdoor walking for one minute and repeat this sequence four times At the end the devices were removed from the subject by the medical staff.The recorded data was downloaded for analysis by the Sponsor"

DEVICE

Study Procedure for Participants That Were Included in the Driving Group

"Subjects were fitted with One lead Holter monitor and the CardiacSense1 watch simultaneously and were tested in the following condition:~1. Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 28 ±3 degree Celsius.~2. Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 22 ±3 degree Celsius.~3. Going from the indoor facility to the car and driving for 30 minutes at least. Subject drove the car in city streets under light traffic conditions. At the end the devices were removed from the subject by the medical staff.The recorded data was downloaded for analysis by the Sponsor"

Trial Locations (1)

62431

Tel Aviv Sourasky Medical Center, Tel Aviv

All Listed Sponsors
lead

CardiacSense Ltd.

INDUSTRY

NCT04353453 - Study to Evaluate the Performance of CardiacSense PPG Sensor | Biotech Hunter | Biotech Hunter