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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Page 1 of 1 (1 locations)

1

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 62431