Clinical trial NCT04176926: Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch
Official title: Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Fitbit LLC
Sponsor class: INDUSTRY
First posted: 2019-11-25
Enrollment: 472
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Through study completion, an average of 4 months
Secondary outcomes:
measure: Confirm the software's ability to produce a waveform clinically equivalent to a Lead I ECG from a clinical reference device (12-lead ECG).
timeFrame: Through study completion, an average of 4 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Orlando
country: United States
facility: Bioclinica Research Orlando
state: Florida
city: The Villages
country: United States
facility: Bioclinica Research The Villages
state: Florida
city: Winfield
country: United States
facility: PMG Research of Dupage
state: Illinois
city: Ames
country: United States
facility: PMG Research of McFarland
state: Iowa
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount
state: North Carolina
city: Statesville
country: United States
facility: PMG Research of Piedmont Healthcare
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston
state: South Carolina
city: Kallithea
country: Greece
facility: Onassis Cardiac Surgery Center
Study officials:
affiliation: Medstar Health Research Institute
name: Venkatesh Raman, MD
role: PRINCIPAL_INVESTIGATOR
References: