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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-06

Study Completion Date

2021-03-08

Brief Summary

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

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Detection Notification

Pulse rate data will be collected from a commercial device worn on the wrist. ECG will be collected from a single lead ambulatory ECG patch worn on the chest. The data from both the commercial wrist-worn device and the ECG patch are not analyzed real-time.

Group Type ACTIVE_COMPARATOR

Single lead ambulatory ECG patch

Intervention Type DIAGNOSTIC_TEST

Single lead ambulatory ECG patch worn on the chest

Non Detection Notification

Pulse rate data will be collected from a commercial device worn on the wrist.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Single lead ambulatory ECG patch

Single lead ambulatory ECG patch worn on the chest

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adults 22 years of age or older
* Capable of giving informed consent
* U.S. resident
* No prior history of atrial fibrillation or atrial flutter
* Fitbit account, with one of the following devices paired:
* Ionic, Versa, Versa Lite, Versa 2, Versa 3, Charge 3, Charge 4, Inspire HR, Inspire 2, or Sense updated to the latest available firmware.

Exclusion Criteria

* Diagnosis or history of Atrial Fibrillation at time of consent
* Diagnosis or history of Atrial Flutter at time of consent
* Current use of anticoagulation medication
* Cardiac pacemaker or implantable cardioverter-defibrillator

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes