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

NCT04380415 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450000

Last updated 2021-03-09

No results posted yet for this study

Summary

Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.

Conditions

Interventions

DIAGNOSTIC_TEST

Single lead ambulatory ECG patch

Single lead ambulatory ECG patch worn on the chest

Sponsors & Collaborators

  • Fitbit LLC

    lead INDUSTRY

Principal Investigators

  • Steven Lubitz, MD, MPH · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-06
Primary Completion
2021-03-08
Completion
2021-03-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04380415 on ClinicalTrials.gov