Study to Evaluate the Performance of CardiacSense PPG Sensor

NCT04353453 | Completed

• 1 other identifier: CL00201
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

Cardiology

Outcome Measures

Primary Outcomes (2)

• PPG individual peak detection

  Comparison of CardiacSense1 PPG individual peak detection to the corresponding recorded activity of an FDA-cleared ECG Holter, on a beat-by-beat basis.

  90 Minutes

• PPG and Holter ECG signals correlation

  Evaluation of the correlation between PPG signals and Holter ECG signals with respect to R-R signal intervals.

  90 Minutes

Secondary Outcomes (2)

• signal intensity under different conditions

  90 minutes

• Adverse events

  90 minutes

Interventions

Study Procedure for Participants That Were Not in the Driving Group DEVICE

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

Study Procedure for Participants That Were Included in the Driving Group DEVICE

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• CardiacSense Ltd.: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 62431, Israel

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: February 19, 2018
• Primary Completion: March 18, 2019
• Study Completion: March 18, 2019
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)