NCT03335800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
419,927

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

November 29, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 30, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

November 2, 2017

Results QC Date

February 22, 2020

Last Update Submit

March 18, 2020

Conditions

Atrial FibrillationArrhythmias, CardiacAtrial Flutter

Outcome Measures

Primary Outcomes (2)

  • 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.

    During ambulatory ECG monitoring (up to 8 days)

  • 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.

    During ambulatory ECG monitoring (up to 8 days)

Secondary Outcomes (2)

  • Concordant AF With App Algorithm Notification

    During ambulatory ECG monitoring (up to 8 days)

  • Self-reported Contact With a Health Care Provider

    90 days to 15 months

Study Arms (1)

Apple Heart Study App

EXPERIMENTAL
Device: Apple Heart Study App

Interventions

Apple Heart Study AppDEVICE

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.

Apple Heart Study App

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

Related Publications (4)

  • Nguyen KT, Yu J, Hedlin H, Phillips AT, Desai S, Cheung L, Kowey PR, Jain SS, Rumsfeld JS, Russo AM, Granger CB, Hills MT, Desai M, Mahaffey KW, Turakhia MP, Perez MV. Racial and Ethnic Representation and Study Engagement in a Siteless Digital Clinical Trial Using a Smartwatch: Findings From the Apple Heart Study. Mayo Clin Proc Digit Health. 2025 Jun 3;3(3):100232. doi: 10.1016/j.mcpdig.2025.100232. eCollection 2025 Sep.

    PMID: 40673279DERIVED

  • 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.

    PMID: 35695137DERIVED

  • 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.

    PMID: 31722151DERIVED

  • 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.

    PMID: 30392584DERIVED

Related Links

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, CardiacAtrial Flutter

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Minang (Mintu) Turakhia, Associate Professor of Medicine, Stanford University
Organization
Associate Professor of Medicine, Stanford University
mintu@stanford.edu
(650) 493-5000

Study Officials

  • Minang (Mintu) Turakhia, MD, MAS

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Marco V. Perez, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, Stanford University

Study Record Dates

First Submitted

November 2, 2017

First Posted

November 8, 2017

Study Start

November 29, 2017

Primary Completion

February 21, 2019

Study Completion

February 21, 2019

Last Updated

March 30, 2020

Results First Posted

March 30, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)