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Clinical trialNCT04176926CompletedObservational

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

SponsorFitbit LLCEnrollment472Atrial Fibrillation
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Greece
  • Onassis Cardiac Surgery Center

    Kallithea, Greece

United States
  • 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

  • Pmg Research of Dupage

    Winfield, Illinois, United States

  • Pmg Research of Mcfarland

    Ames, Iowa, United States

  • Pmg Research of Rocky Mount

    Rocky Mount, North Carolina, United States

  • Pmg Research of Piedmont Healthcare

    Statesville, North Carolina, United States

  • Pmg Research of Wilmington

    Wilmington, North Carolina, United States

  • Pmg Research of Charleston

    Mt. Pleasant, South Carolina, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
29 Oct 2019
Primary completion
20 Dec 2019
Completion
2 Mar 2020
Last update posted
9 Apr 2020
Registered enrollment
472
Registry id
NCT04176926
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.