Apple Heart Study

Clinical Trial Details

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

This research study evaluates 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 people can participate in the study.

Key Findings

  • Primary endpoints:
    Irregular pulse detected in 0.52% of wearers (low rates). These received an ECG patch to wear for up to 7 days. 34% of those were determined to have AF.
     
  • Other Endpoints:
    Notification positive predictive value was 0.84 (84% of notifications also had an ECG showing AF). At 90 days, only 57% of those who received notification contacted their provider. Irregular pulse notifications happened more in those ≥ 65 years old (3.2%) and in men (0.7% vs 0.26% in women).

Apple Heart Study Primary Investigator

Marco Perez, MD summarizes the results of the Apple Heart Study which he presented during ACC 2019 in New Orleans. The trial tested the efficacy of a smart watch application in detecting heart rhythm abnormalities.

Swipe table left to see full data

Apple Heart Study
Apple Heart Study Watch app irregular pulse notification results
AF > 30 seconds0.52%
Confirmed AF on ambulatory ECG34%
Provider Contact by 90 days57%
Age of irregular pulse notification receivers3.2% ≥ 65 years old
Men vs women - irregular pulse notification receivers0.7% men vs 0.26% women
Positive predictive value for notificationIrregular pulse notifications:
AF detected on ECG patch: 72
Positive notifications: 86
PPV: 0.84

Purpose: To evaluate whether the Apple Heart Study Watch app has the potential to be used to identify arrhythmias such as AF.

Trial Design: 419,093 participants, ≥ 22 years old; single-arm; series 1 or later Apple watch with OS version 4.0 or later paired with iPhone 5S or later. Interventional, prospective, unmasked, single-arm, screening trial. Virtual screening; and data collection and telehealth physician study visits by video chat. The Apple Watch uses photoplethysmography which measures blood flow and changes that may suggest irregular rhythms.

Primary Endpoints: AF > 30 seconds during up to 8 days of ambulatory ECG monitoring for patients ≥ 65 years old. Confirmed AF by up to 8 days of ambulatory ECG monitoring after app detection.

Results: Irregular pulse detected in 0.52% of wearers (low rates). These received an ECG patch to wear for up to 7 days. 34% of those were determined to have AF. Notification positive predictive value was 0.84 (84% of notifications also had an ECG showing AF). At 90 days, only 57% of those who received notification contacted their provider. Irregular pulse notifications happened more in those ≥ 65 years old (3.2%) and in men (0.7% vs 0.25% in women).

Conclusions: In this population, there were a low number of irregular pulse notifications. PPV of 0.84 suggests the ability for correct identification of these irregularities in these people.

Background

This trial evaluates whether the Apple Heart Study Watch app has the potential to identify arrhythmias such as AF.

Trial design: Interventional, prospective, unmasked, single-arm, screening trial. Studies the Apple Heart Study app, a mobile medical app, to analyze pulse rate data and ID irregular heart rhythms. Virtual screening and data collection and telehealth physician study visits by video chat. The Apple Watch uses photoplethysmography which measures blood flow and changes that may suggest irregular rhythms.

Trial population: 419,093 participants, ≥ 22 years old, single-arm. Series 1 or later Apple watch with OS version 4.0 or later paired with iPhone 5S or later.

Primary endpoints:

  • AF > 30 seconds during up to 8 days of ambulatory ECG monitoring with irregular pulse watch notification (IPWN).
  • Confirmed AF by ECG monitoring during up to 8 days of ambulatory ECG monitoring after app detection.

Principal Investigators: Minang (Mintu) Turakhia, MD, MAS and Marco V. Perez, MD, Stanford University

Sponsors and Collaborators: Apple, Inc.

References:

Key Words
Atrial fibrillation, atrial flutter, arrhythmias, heart diseases, cardiovascular diseases

Related Clinical Topics
Familial?atrial?fibrillation, AF, stroke, Electrophysiology and Arrhythmias, general cardiology

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