NCT04380415

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450,000

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 6, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2021

Completed
Last Updated

March 9, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

May 5, 2020

Last Update Submit

March 8, 2021

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Simultaneous measurement of AF ≥ 30 seconds with detection

    Simultaneous measurement of AF ≥ 30 seconds on ECG patch monitor during any of the pulse tachograms that generate the first Irregular Heart Rhythm Detection during ECG monitoring.

    7 days

Secondary Outcomes (1)

  • Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms

    7 days

Study Arms (2)

Detection Notification

ACTIVE COMPARATOR

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.

Diagnostic Test: Single lead ambulatory ECG patch

Non Detection Notification

NO INTERVENTION

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

Interventions

Single lead ambulatory ECG patchDIAGNOSTIC_TEST

Single lead ambulatory ECG patch worn on the chest

Detection Notification

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

PlushCare

San Francisco, California, 94107, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Lubitz SA, McConnell MV, Selvaggi C, Krishnamoorthy A, Atlas SJ, McManus DD, Pagoto S, Singer DE, Pantelopoulos A, Foulkes AS, Faranesh AZ. Wearable Irregular Heart Rhythm Detection Recurrences and Electrocardiographic Atrial Fibrillation Confirmation: The Fitbit Heart Study. Circ Arrhythm Electrophysiol. 2025 Jul;18(7):e013565. doi: 10.1161/CIRCEP.124.013565. Epub 2025 Jun 25.

    PMID: 40557492DERIVED

  • Lubitz SA, Faranesh AZ, Selvaggi C, Atlas SJ, McManus DD, Singer DE, Pagoto S, McConnell MV, Pantelopoulos A, Foulkes AS. Detection of Atrial Fibrillation in a Large Population Using Wearable Devices: The Fitbit Heart Study. Circulation. 2022 Nov 8;146(19):1415-1424. doi: 10.1161/CIRCULATIONAHA.122.060291. Epub 2022 Sep 23.

    PMID: 36148649DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Steven Lubitz, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 8, 2020

Study Start

May 6, 2020

Primary Completion

March 8, 2021

Study Completion

March 8, 2021

Last Updated

March 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)