Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias

NCT ID: NCT03769207

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-08
• Study Completion Date: 2019-08-20

Brief Summary

This post-marketing study is conducted to characterize the ability of Apple Watch rhythm analysis software to identify Atrial Fibrillation (AF) and facilitate subsequent clinical evaluation among users who contact AppleCare.

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Flutter

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ambulatory ECG

Group Type: OTHER

Ambulatory ECG

Intervention Type: DEVICE

Eligible participants are asked to wear the ambulatory ECG monitor

Interventions

Ambulatory ECG

Eligible participants are asked to wear the ambulatory ECG monitor

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Possession of the following at time of eligibility screening:

• iPhone (5s or later) with iOS version 12.1.1 or later defined as iPhone model/iOS version used to complete screening eligibility.
• Apple Watch (Series 1-4) with watchOS version 5.1.2 or later defined as Apple Watch model/watchOS paired with iPhone used to complete screening eligibility

2. At least one of the following by self-report before consent:

• Irregular Rhythm Notification
• ECG app classification of Atrial Fibrillation
• ECG app classification of Inconclusive defined as "Inconclusive," "Heart Rate Over 120," or "Heart Rate Under 50"

3. Age ≥ 22 years at time of eligibility screening

4. Current resident of the United States at time of eligibility screening, and will reside in the United States for the length of the study

5. Proficient in written and spoken English

6. Valid phone number associated with iPhone, ascertained from self-report

7. Valid email address, ascertained from self-report

Exclusion Criteria

1. Shared iCloud account

2. Shared AppleWatch

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Apple Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Marco Perez

Assistant Professor of Medicine (Cardiovascular Medicine)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco V Perez, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Minang (Mintu) Turakhia, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

48787

Identifier Type: OTHER

Identifier Source: secondary_id

1.2

Identifier Type: -

Identifier Source: org_study_id