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

Primary Purpose

Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Apple Heart Study App

About this trial

This is an interventional screening trial for Atrial Fibrillation

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check:

iPhone (5s or later) with iOS version 11.0 or later defined as iPhone model/iOS version used to complete screening eligibility.
Apple Watch (Series 1 or later) with watchOS version 4.0 or later defined as Apple Watch model/watchOS paired with iPhone used to complete screening eligibility.
Current resident of the United States at time of eligibility screening, defined by self-reported state of residence within the 50 states of the United States or District of Columbia.
Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone.
Valid phone number associated with iPhone, ascertained from self-report.
Valid email address, ascertained from self-report.

Exclusion Criteria:

Self-reported diagnosis of Atrial Fibrillation.
Self-reported diagnosis of Atrial Flutter.
Currently on anti-coagulation therapy.

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apple Heart Study App

Arm Description

Outcomes

Primary Outcome Measures

Atrial Fibrillation (AF) of Greater Than 30 Seconds

Proportion of notified participants who received an irregular pulse notification and that had AF detected on the ambulatory ECG.

Confirmed AF With a Detection by a Component of the App

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.

Secondary Outcome Measures

Concordant AF With App Algorithm Notification

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

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.

Full Information

NCT ID

NCT03335800

First Posted

November 2, 2017

Last Updated

March 18, 2020

Sponsor

Apple Inc.

Collaborators

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT03335800

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

November 29, 2017 (Actual)

Primary Completion Date

February 21, 2019 (Actual)

Study Completion Date

February 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Apple Inc.

Collaborators

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The Apple Heart Study (AHS) is a research study conducted to evaluate whether the Apple Heart Study App can use data collected on the Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions such as atrial fibrillation. Up to 500,000 can participate in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

419927 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apple Heart Study App

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Apple Heart Study App

Intervention Description

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.

Primary Outcome Measure Information:

Title

Atrial Fibrillation (AF) of Greater Than 30 Seconds

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)

Title

Confirmed AF With a Detection by a Component of the App

Description

Time Frame

During ambulatory ECG monitoring (up to 8 days)

Secondary Outcome Measure Information:

Title

Concordant AF With App Algorithm Notification

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)

Title

Self-reported Contact With a Health Care Provider

Description

Time Frame

90 days to 15 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check: iPhone (5s or later) with iOS version 11.0 or later defined as iPhone model/iOS version used to complete screening eligibility. Apple Watch (Series 1 or later) with watchOS version 4.0 or later defined as Apple Watch model/watchOS paired with iPhone used to complete screening eligibility. Current resident of the United States at time of eligibility screening, defined by self-reported state of residence within the 50 states of the United States or District of Columbia. Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone. Valid phone number associated with iPhone, ascertained from self-report. Valid email address, ascertained from self-report. Exclusion Criteria: Self-reported diagnosis of Atrial Fibrillation. Self-reported diagnosis of Atrial Flutter. Currently on anti-coagulation therapy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Minang (Mintu) Turakhia, MD, MAS

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marco V. Perez, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35695137

Citation

Garcia A, Balasubramanian V, Lee J, Gardner R, Gummidipundi S, Hung G, Ferris T, Cheung L, Granger C, Kowey P, Rumsfeld J, Russo A, Hills MT, Talati N, Nag D, Stein J, Tsay D, Desai S, Mahaffey K, Turakhia M, Perez M, Hedlin H, Desai M. Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials. J Biopharm Stat. 2022 May 4;32(3):496-510. doi: 10.1080/10543406.2022.2080698. Epub 2022 Jun 12.

Results Reference

derived

PubMed Identifier

31722151

Citation

Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.

Results Reference

derived

PubMed Identifier

30392584

Citation

Turakhia MP, Desai M, Hedlin H, Rajmane A, Talati N, Ferris T, Desai S, Nag D, Patel M, Kowey P, Rumsfeld JS, Russo AM, Hills MT, Granger CB, Mahaffey KW, Perez MV. Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: The Apple Heart Study. Am Heart J. 2019 Jan;207:66-75. doi: 10.1016/j.ahj.2018.09.002. Epub 2018 Sep 8.

Results Reference

derived

Links:

URL

http://med.stanford.edu/appleheartstudy.html

Description

Website for study information

Learn more about this trial

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

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