Status:
COMPLETED
Study to Evaluate the Performance of CardiacSense PPG Sensor
Lead Sponsor:
CardiacSense Ltd.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
NA
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 design...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04353453
Start Date
February 19 2018
End Date
March 18 2019
Last Update
April 20 2020
Active Locations (1)
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1
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 62431