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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04176926
• Other study ID #: 129-0360-01
• Status: Completed
• Start date: October 29, 2019
• Est. completion date: March 2, 2020

Study information

• Verified date: April 2020
• Source: Fitbit Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: March 2, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Greece	Onassis Cardiac Surgery Center	Kallithea
United States	PMG Research of McFarland	Ames	Iowa
United States	PMG Research of Charleston	Mount Pleasant	South Carolina
United States	Bioclinica Research Orlando	Orlando	Florida
United States	PMG Research of Rocky Mount	Rocky Mount	North Carolina
United States	PMG Research of Piedmont Healthcare	Statesville	North Carolina
United States	Bioclinica Research The Villages	The Villages	Florida
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	PMG Research of Dupage	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Fitbit Inc

Countries where clinical trial is conducted

United States,  Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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