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Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch

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: NCT04176926
Recruitment Status : Completed
First Posted : November 25, 2019
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Fitbit Inc

Study Description
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Brief Summary:
The goal of this study is to validate the Fitbit ECG software algorithm's ability to detect atrial fibrillation using data derived from a Fitbit wrist-worn consumer device that features a single lead ECG. The performance of the software application will be measured against centralized Core Lab physician-adjudicated 12-lead ECG tracings from FDA cleared ECG monitors as reference standards. The Fitbit software is intended as a pre-screening technology. It should identify candidates who may benefit from further evaluation. The software is not intended to be a diagnostic system.

Condition or disease Intervention/treatment
Atrial Fibrillation Diagnostic Test: Electrocardiogram

Study Design
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Study Type : Observational
Actual Enrollment : 472 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch
Actual Study Start Date : October 29, 2019
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : March 2, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1: SR
Group 1: Subjects in the sinus rhythm (SR) cohort should not have any history of atrial fibrillation and should not be in atrial fibrillation or other atrial arrhythmia at the time of enrollment based on the screening ECG.
 Diagnostic Test: Electrocardiogram
Diagnostic Test: Simultaneous assessment of heart rhythm by 12-lead ECG and wearable device characterization of heart rhythm.
Group 2: AF
Group 2: Subjects in the atrial fibrillation (AF) cohort must have a known history of AF and must be in AF at the time of enrollment based on the screening ECG.
 Diagnostic Test: Electrocardiogram
Diagnostic Test: Simultaneous assessment of heart rhythm by 12-lead ECG and wearable device characterization of heart rhythm.


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the software algorithm's ability to classify a heart rhythm as sinus rhythm or atrial fibrillation from a waveform equivalent to a Lead I ECG. [ Time Frame: Through study completion, an average of 4 months ]
    Sensitivity and specificity of the software algorithm in classifying sinus rhythm and atrial fibrillation from the equivalent of a Lead I ECG waveform, compared with physician's interpretation of a standard 12-lead ECG. Performance goals are 90% (sensitivity) and 92% (specificity)


Secondary Outcome Measures :
  1. Confirm the software's ability to produce a waveform clinically equivalent to a Lead I ECG from a clinical reference device (12-lead ECG). [ Time Frame: Through study completion, an average of 4 months ]

    Qualitative assessment of the software produced waveform to reference Lead I from 12-lead ECG. Goal is >0.80 of strips appear to overlay to the unaided eye.

    Comparison of R-wave amplitudes between the Fitbit waveform and the clinical reference. Goal is >0.80 of R-wave amplitudes to be within 2mm.



Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited at the individual clinical sites. Subjects may be recruited during routine clinic visits or may be asked to come in specifically for this study.
Criteria

Inclusion Criteria:

  • Women and men 22 years of age or older
  • Capable of giving informed consent
  • Sufficient manual dexterity to capture an ECG from the Fitbit wrist-worn device.
  • Subjects in the atrial fibrillation (AF) cohort must have a known history of AF and must be in -AF at the time of enrollment based on the screening ECG

Exclusion Criteria:

  • Anti-arrhythmic (rhythm control) medication use (such as amiodarone or flecainide)
  • Cardiac pacemaker or implantable cardioverter-defibrillator
  • History of a life-threatening rhythm such as ventricular tachycardia or ventricular fibrillation
  • Subjects in the sinus rhythm (SR) cohort should not have any history of atrial fibrillation and should not be in atrial fibrillation or other atrial arrhythmia at the time of enrollment based on the screening ECG
Contacts and Locations
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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): NCT04176926


Locations
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United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Bioclinica Research Orlando
Orlando, Florida, United States, 32806
Bioclinica Research The Villages
The Villages, Florida, United States, 32162
United States, Illinois
PMG Research of Dupage
Winfield, Illinois, United States, 60190
United States, Iowa
PMG Research of McFarland
Ames, Iowa, United States, 50010
United States, North Carolina
PMG Research of Rocky Mount
Rocky Mount, North Carolina, United States, 27804
PMG Research of Piedmont Healthcare
Statesville, North Carolina, United States, 28625
PMG Research of Wilmington
Wilmington, North Carolina, United States, 28401
United States, South Carolina
PMG Research of Charleston
Mount Pleasant, South Carolina, United States, 29407
Greece
Onassis Cardiac Surgery Center
Kallithea, Greece
Sponsors and Collaborators
Fitbit Inc
Investigators
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Principal Investigator: Venkatesh Raman, MD Medstar Health Research Institute
More Information
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Responsible Party: Fitbit Inc
ClinicalTrials.gov Identifier: NCT04176926    
Other Study ID Numbers: 129-0360-01
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes