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
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Diagnostic Test: Single lead ambulatory ECG patch||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||450000 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- 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.
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
|United States, California|
|San Francisco, California, United States, 94107|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Steven Lubitz, MD, MPH||Massachusetts General Hospital|