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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04380415
Recruitment Status : Completed
First Posted : May 8, 2020
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Fitbit Inc

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Diagnostic Test: Single lead ambulatory ECG patch Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450000 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Fitbit Atrial Fibrillation From PPG Data Validation Study
Actual Study Start Date : May 6, 2020
Actual Primary Completion Date : March 8, 2021
Actual Study Completion Date : March 8, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Diagnostic Test: Single lead ambulatory ECG patch
Single lead ambulatory ECG patch worn on the chest

No Intervention: Non Detection Notification
Pulse rate data will be collected from a commercial device worn on the wrist.



Primary Outcome Measures :
  1. Simultaneous measurement of AF ≥ 30 seconds with detection [ Time Frame: 7 days ]
    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.


Secondary Outcome Measures :
  1. Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms [ Time Frame: 7 days ]
    Simultaneous measurement of AF ≥ 30 seconds on the ECG patch monitor during each of the pulse tachograms that contributed to the first Irregular Heart Rhythm Detection, among those detections confirmed by ECG.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04380415


Locations
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United States, California
PlushCare
San Francisco, California, United States, 94107
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Fitbit Inc
Investigators
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Principal Investigator: Steven Lubitz, MD, MPH Massachusetts General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fitbit Inc
ClinicalTrials.gov Identifier: NCT04380415    
Other Study ID Numbers: 129-0469-01
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes