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

Fitbit LLC472 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

472

Conditions

Atrial Fibrillation

Interventions

ElectrocardiogramDIAGNOSTIC_TEST

Diagnostic Test: Simultaneous assessment of heart rhythm by 12-lead ECG and wearable device characterization of heart rhythm.

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Bioclinica Research Orlando

Orlando, Florida, United States

Bioclinica Research The Villages

The Villages, Florida, United States

Outcomes

Primary Outcomes

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)

Time frame: Through study completion, an average of 4 months

Secondary Outcomes

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.

Time frame: Through study completion, an average of 4 months

Data from ClinicalTrials.gov

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