Back to resultsValidation of Software for Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable Smartwatch
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single lead ambulatory ECG patch
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation
Eligibility 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
Sites / Locations
- PlushCare
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Detection Notification
Non Detection Notification
Arm Description
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.
Pulse rate data will be collected from a commercial device worn on the wrist.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04380415
Brief Title
Validation of Software for Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable Smartwatch
Official Title
Fitbit Atrial Fibrillation From PPG Data Validation Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 6, 2020 (Actual)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
March 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fitbit LLC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
450000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Detection Notification
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non Detection Notification
Arm Type
No Intervention
Arm Description
Pulse rate data will be collected from a commercial device worn on the wrist.
Intervention Type
Diagnostic Test
Intervention Name(s)
Single lead ambulatory ECG patch
Intervention Description
Single lead ambulatory ECG patch worn on the chest
Primary Outcome Measure Information:
Title
Simultaneous measurement of AF ≥ 30 seconds with detection
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms
Description
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.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Lubitz, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
PlushCare
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36148649
Citation
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.
Results Reference
derived
Learn more about this trial
Validation of Software for Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable Smartwatch
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