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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: Electrocardiogram

• Study Type: Observational
• Enrollment (Actual): 472

Contacts and Locations

Study Locations

• Greece
  • Kallithea, Greece
    • Onassis Cardiac Surgery Center
• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Orlando, Florida, United States, 32806
      • Bioclinica Research Orlando
    • The Villages, Florida, United States, 32162
      • Bioclinica Research The Villages
  • Illinois
    • Winfield, Illinois, United States, 60190
      • PMG Research of DuPage
  • Iowa
    • Ames, Iowa, United States, 50010
      • PMG Research of McFarland
  • North Carolina
    • Rocky Mount, North Carolina, United States, 27804
      • PMG Research of Rocky Mount
    • Statesville, North Carolina, United States, 28625
      • PMG Research of Piedmont Healthcare
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29407
      • PMG Research of Charleston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	Through study completion, an average of 4 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fitbit Inc
• Investigators: Principal Investigator: Venkatesh Raman, MD, MedStar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2019
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): March 2, 2020

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 129-0360-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No