Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
|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: NCT03335800|
Recruitment Status : Active, not recruiting
First Posted : November 8, 2017
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter||Device: Apple Heart Study App||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias|
|Actual Study Start Date :||November 29, 2017|
|Estimated Primary Completion Date :||January 31, 2019|
|Estimated Study Completion Date :||January 31, 2019|
|Experimental: Apple Heart Study App||
Device: Apple Heart Study App
The Apple Heart Study app is a mobile medical app that analyzes pulse rate data. The app identifies episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
- Atrial Fibrillation (AF) of greater than 30 seconds duration [ Time Frame: During ambulatory ECG monitoring (up to 8 days) ]Detected on ambulatory ECG monitoring for a participant who received an irregular pulse watch notification.
- Confirmed AF with a detection by a component of the app [ Time Frame: During ambulatory ECG monitoring (up to 8 days) ]Simultaneous ambulatory ECG monitoring indicating an irregular rhythm consistent with AF during time intervals when an app component is positive for an irregular pulse among those who received an irregular heartbeat notification.
- Concordant AF with app algorithm notification [ Time Frame: During ambulatory ECG monitoring (up to 8 days) ]Simultaneous ambulatory ECG monitoring indicating an irregular rhythm consistent with AF when the app based algorithm is positive for an irregular pulse among those who received a notification.
- Self-reported contact with a health care provider [ Time Frame: Up to 15 months ]Within 90 days following an irregular pulse watch notification
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): NCT03335800
|United States, California|
|Stanford, California, United States, 94304|
|Principal Investigator:||Minang (Mintu) Turakhia, MD, MAS||Stanford University|
|Principal Investigator:||Marco V. Perez, MD||Stanford University|