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

Primary Purpose

Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ambulatory ECG

About this trial

This is an interventional other 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:
- 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
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"
Age ≥ 22 years at time of eligibility screening
Current resident of the United States at time of eligibility screening, and will reside in the United States for the length of the study
Proficient in written and spoken English
Valid phone number associated with iPhone, ascertained from self-report
Valid email address, ascertained from self-report

Exclusion Criteria:

Shared iCloud account
Shared AppleWatch

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ambulatory ECG

Arm Description

Outcomes

Primary Outcome Measures

Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration

Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification

Secondary Outcome Measures

Arrhythmias Other Than AF

Detected on an ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification

Self-reported Contact With Healthcare Provider

Full Information

NCT ID

NCT03769207

First Posted

December 6, 2018

Last Updated

September 25, 2020

Sponsor

Apple Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03769207

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

December 8, 2018 (Actual)

Primary Completion Date

July 5, 2019 (Actual)

Study Completion Date

August 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Apple Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

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

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ambulatory ECG

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Ambulatory ECG

Intervention Description

Eligible participants are asked to wear the ambulatory ECG monitor

Primary Outcome Measure Information:

Title

Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration

Description

Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification

Time Frame

During ambulatory ECG Monitoring (up to 8 days)

Secondary Outcome Measure Information:

Title

Arrhythmias Other Than AF

Description

Detected on an ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification

Time Frame

During ambulatory ECG Monitoring (up to 8 days)

Title

Self-reported Contact With Healthcare Provider

Time Frame

Between 15 to 90 days following enrollment

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: 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 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" Age ≥ 22 years at time of eligibility screening Current resident of the United States at time of eligibility screening, and will reside in the United States for the length of the study Proficient in written and spoken English Valid phone number associated with iPhone, ascertained from self-report Valid email address, ascertained from self-report Exclusion Criteria: Shared iCloud account Shared AppleWatch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marco V Perez, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Minang (Mintu) Turakhia, MD, MAS

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

Learn more about this trial

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

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