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

NCT03769207 | Completed Results FDA Device

• 2 other identifiers: 1.248787
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  During ambulatory ECG Monitoring (up to 8 days)

Secondary Outcomes (2)

• Arrhythmias Other Than AF

  During ambulatory ECG Monitoring (up to 8 days)

• Self-reported Contact With Healthcare Provider

  Between 15 to 90 days following enrollment

Study Arms (1)

Ambulatory ECG

OTHER

Device: Ambulatory ECG

Interventions

Ambulatory ECG DEVICE

Eligible participants are asked to wear the ambulatory ECG monitor

Ambulatory ECG

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Shared iCloud account
• Shared AppleWatch

Sponsors & Collaborators

• Apple Inc.: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Flutter

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Limitations and Caveats

The small number of enrolled participants prevents us from drawing meaningful conclusions from this study.

Results Point of Contact

• Title: Marco Perez, Associate Professor of Medicine
• Organization: Stanford University

mvperez@stanford.edu

(650) 723-9363

Study Officials

• Marco V Perez, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Minang (Mintu) Turakhia, MD, MAS

  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: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Cardiovascular Medicine)

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 7, 2018
• Study Start: December 8, 2018
• Primary Completion: July 5, 2019
• Study Completion: August 20, 2019
• Last Updated: October 20, 2020
• Results First Posted: October 20, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)