Atrial Fibrillation Clinical Trial
Official title:
Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch
NCT number | NCT04176926 |
Other study ID # | 129-0360-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 29, 2019 |
Est. completion date | March 2, 2020 |
Verified date | April 2020 |
Source | Fitbit Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Fitbit Inc |
United States, Greece,
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 |
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