Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch
1 other identifier
observational
472
2 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Shorter than P25 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 29, 2019
CompletedFirst Submitted
Initial submission to the registry
November 21, 2019
CompletedFirst Posted
Study publicly available on registry
November 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2020
CompletedApril 9, 2020
April 1, 2020
2 months
November 21, 2019
April 7, 2020
Conditions
Outcome Measures
Primary Outcomes (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.
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 Outcomes (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).
Through study completion, an average of 4 months
Study Arms (2)
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.
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.
Interventions
Diagnostic Test: Simultaneous assessment of heart rhythm by 12-lead ECG and wearable device characterization of heart rhythm.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fitbit LLClead
Study Sites (10)
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Bioclinica Research Orlando
Orlando, Florida, 32806, United States
Bioclinica Research The Villages
The Villages, Florida, 32162, United States
PMG Research of Dupage
Winfield, Illinois, 60190, United States
PMG Research of McFarland
Ames, Iowa, 50010, United States
PMG Research of Rocky Mount
Rocky Mount, North Carolina, 27804, United States
PMG Research of Piedmont Healthcare
Statesville, North Carolina, 28625, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
PMG Research of Charleston
Mt. Pleasant, South Carolina, 29407, United States
Onassis Cardiac Surgery Center
Kallithea, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Venkatesh Raman, MD
Medstar Health Research Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2019
First Posted
November 25, 2019
Study Start
October 29, 2019
Primary Completion
December 20, 2019
Study Completion
March 2, 2020
Last Updated
April 9, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share