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Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias

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ClinicalTrials.gov Identifier: NCT03335800
Recruitment Status : Completed
First Posted : November 8, 2017
Results First Posted : March 30, 2020
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Minang (Mintu) Turakhia, Stanford University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Conditions Atrial Fibrillation
Arrhythmias, Cardiac
Atrial Flutter
Intervention Device: Apple Heart Study App
Enrollment 419927
Recruitment Details Participants downloaded the app; those with irregular pulse notification had a first teleconference visit with telehealth provider; an ECG patch was shipped to eligible participants to wear for 7 days, then they returned the patch for analysis and had a second teleconference visit to review the findings with the telehealth provider.
Pre-assignment Details  
Arm/Group Title Apple Heart Study (AHS) App Users
Hide Arm/Group Description Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
Period Title: Overall Study
Started 419927
Received Irregular Pulse Notification 2161
Attended First Study Visit 945
ECG Patch Shipped 658
ECG Patch Returned for Analysis 450
Attended Second Study Visit 396
Completed 396
Not Completed 419531
Arm/Group Title Apple Heart Study (AHS) App Users
Hide Arm/Group Description Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
Overall Number of Baseline Participants 419927
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 419927 participants
41  (13)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 419927 participants
Female
177087
  42.2%
Male
238700
  56.8%
Other
396
   0.1%
Not Reported
3114
   0.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 419927 participants
White
286190
  68.2%
Hispanic
48775
  11.6%
Black
32275
   7.7%
Asian
26156
   6.2%
American Indian
4696
   1.1%
Pacific Islander
1493
   0.4%
Middle Eastern
3652
   0.9%
Other or mixed race
7958
   1.9%
Not Reported
8102
   1.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 419927 participants
419927
 100.0%
1.Primary Outcome
Title Atrial Fibrillation (AF) of Greater Than 30 Seconds
Hide Description Proportion of notified participants who received an irregular pulse notification and that had AF detected on the ambulatory ECG.
Time Frame During ambulatory ECG monitoring (up to 8 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participant who returned ECG Patch
Arm/Group Title Apple Heart Study (AHS) App Users
Hide Arm/Group Description:
Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
Overall Number of Participants Analyzed 450
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: Proportion of participants
0.34
(0.29 to 0.39)
2.Primary Outcome
Title Confirmed AF With a Detection by a Component of the App
Hide Description Simultaneous ambulatory ECG monitoring indicating an irregular rhythm consistent with AF during time intervals when an app component (tachogram) is positive for an irregular pulse among those who received an irregular heartbeat notification.
Time Frame During ambulatory ECG monitoring (up to 8 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apple Heart Study (AHS) App Users
Hide Arm/Group Description:
Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
Overall Number of Participants Analyzed 450
Overall Number of Units Analyzed
Type of Units Analyzed: Tachograms
2089
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: Proportion of Tachograms with AF
0.71
(0.69 to 0.74)
3.Secondary Outcome
Title Concordant AF With App Algorithm Notification
Hide Description 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.
Time Frame During ambulatory ECG monitoring (up to 8 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apple Heart Study (AHS) App Users
Hide Arm/Group Description:
Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
Overall Number of Participants Analyzed 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of Participants
0.84
(0.76 to 0.92)
4.Secondary Outcome
Title Self-reported Contact With a Health Care Provider
Hide Description Percentage of participant who self-reported contact with a health care provider within 90 days following an irregular pulse watch notification. Participants could self-report this health-care provider contact from 90 days following notification until the study survey went offline at end of study.
Time Frame 90 days to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apple Heart Study (AHS) App Users
Hide Arm/Group Description:
Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
Overall Number of Participants Analyzed 1376
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
57
(54 to 60)
Time Frame 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Apple Heart Study (AHS) App Users
Hide Arm/Group Description Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
All-Cause Mortality
Apple Heart Study (AHS) App Users
Affected / at Risk (%)
Total   2/419927 (0.00%) 
Hide Serious Adverse Events
Apple Heart Study (AHS) App Users
Affected / at Risk (%)
Total   62/419927 (0.01%) 
Cardiac disorders   
Atrial Fibrilation *  40/419927 (0.01%) 
Atrial Flutter *  1/419927 (0.00%) 
Chest Pain *  3/419927 (0.00%) 
Coronary Artery Disease *  1/419927 (0.00%) 
Death *  1/419927 (0.00%) 
Increased frequency of Premature Ventricular Contractions (PVC) *  1/419927 (0.00%) 
Left bundle branch block *  1/419927 (0.00%) 
Mitral regurgitation *  1/419927 (0.00%) 
Mitral Valve Disease *  1/419927 (0.00%) 
Myocardial Infarction *  1/419927 (0.00%) 
Palpitations *  1/419927 (0.00%) 
Shortness of Breath *  1/419927 (0.00%) 
Syncope *  3/419927 (0.00%) 
Congenital, familial and genetic disorders   
Atrial Septal Defect diagnosed *  1/419927 (0.00%) 
Gastrointestinal disorders   
Diarrhea *  1/419927 (0.00%) 
Pancreatitis *  2/419927 (0.00%) 
General disorders   
Chest Pain *  1/419927 (0.00%) 
Drug Reaction *  1/419927 (0.00%) 
Fall *  1/419927 (0.00%) 
Immune system disorders   
Allergic reaction *  1/419927 (0.00%) 
Infections and infestations   
Pneumonia *  1/419927 (0.00%) 
Shortness of breath *  1/419927 (0.00%) 
Injury, poisoning and procedural complications   
Trauma *  1/419927 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Shortness of Breath *  1/419927 (0.00%) 
Surgical and medical procedures   
Procedural Complication *  1/419927 (0.00%) 
Vascular disorders   
Stroke *  1/419927 (0.00%) 
Subdural hematoma *  1/419927 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Apple Heart Study (AHS) App Users
Affected / at Risk (%)
Total   0/419927 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Minang (Mintu) Turakhia, Associate Professor of Medicine, Stanford University
Organization: Associate Professor of Medicine, Stanford University
Phone: (650) 493-5000
EMail: mintu@stanford.edu
Layout table for additonal information
Responsible Party: Minang (Mintu) Turakhia, Stanford University
ClinicalTrials.gov Identifier: NCT03335800    
Other Study ID Numbers: 1.0
First Submitted: November 2, 2017
First Posted: November 8, 2017
Results First Submitted: February 22, 2020
Results First Posted: March 30, 2020
Last Update Posted: March 30, 2020