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

NCT04176926 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 472

Last updated 2020-04-09

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Electrocardiogram

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

Sponsors & Collaborators

  • Fitbit LLC

    lead INDUSTRY

Principal Investigators

  • Venkatesh Raman, MD · Medstar Health Research Institute

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-29
Primary Completion
2019-12-20
Completion
2020-03-02

Countries

  • United States
  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04176926 on ClinicalTrials.gov