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Study to Evaluate the Performance of CardiacSense PPG Sensor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04353453
Recruitment Status : Completed
First Posted : April 20, 2020
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
CardiacSense Ltd.

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Study Procedure for Participants That Were Not in the Driving Group Device: Study Procedure for Participants That Were Included in the Driving Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single-Center, Controlled Study to Evaluate the Performance of CardiacSense PPG Sensor in the CardiacSense1 Device
Actual Study Start Date : February 19, 2018
Actual Primary Completion Date : March 18, 2019
Actual Study Completion Date : March 18, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. PPG individual peak detection [ Time Frame: 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.

  2. PPG and Holter ECG signals correlation [ Time Frame: 90 Minutes ]
    Evaluation of the correlation between PPG signals and Holter ECG signals with respect to R-R signal intervals.


Secondary Outcome Measures :
  1. signal intensity under different conditions [ Time Frame: 90 minutes ]
    Examination of PPG signal optic parameters (LED current, LED intensity) and signal intensity under different conditions.

  2. Adverse events [ Time Frame: 90 minutes ]
    Rate of Adverse events related or unrelated to the study device.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353453


Locations
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Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 62431
Sponsors and Collaborators
CardiacSense Ltd.
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Responsible Party: CardiacSense Ltd.
ClinicalTrials.gov Identifier: NCT04353453    
Other Study ID Numbers: CL00201
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD is not available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CardiacSense Ltd.:
Cardiology
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes