Smart Watch iECG for the Detection of Cardiac Arrhythmias

Feasibility and Reliability of Smart Watch iECG for the Detection of Cardiac Arrhythmias (The Leipzig Apple Heart Rhythm Study)

This study aims to assess the feasibility and reliability of smart watch iECG provided by the Apple Watch/Apple iPhone for the detection of different cardiac arrhythmias. In this study, results from a 12-lead ECG will be set as the gold standard for the arrhythmia diagnosis, and results from the smart watch iECG (Apple watch/Apple iPhone application and Cardiologist's interpretations) as the index tests. The iECG tracings will be recorded simultaneously, starting and ending at the same time as the standard 12-lead ECG, using the built-in sensors of a smart watch (Apple Watch Series 4) with the ECG application.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac
• Intervention / Treatment: Device: iECG recording

Detailed Description

This diagnostic accuracy study is an investigator-initiated trial to evaluate the value of a smart watch-based iECG for detection of cardiac arrhythmias.

iECG tracings will be recorded simultaneously, starting and ending at the same time as the standard 12-lead ECG, using the built-in sensors of a smart watch (Apple Watch Series 4) with the market version of the ECG application (Apple Inc., California). Participants will be advised to lie down in a supine position and breathe spontaneously. All recording will be done by trained study personnel.

All iECG and 12-lead ECG recordings will be presented in PDF format as our references. Saved formats will be transferred to our Telemonitoring Center for further analysis and processing.

Results from a 12-lead ECG will be considered as the gold standard for the measurement of heart rhythms and the arrhythmia diagnosis. All 12-lead ECGs recordings will be analyzed by 2 blinded cardiologists and will be categorized as "Sinus rhythm", "High or low heart rate", "Atrial fibrillation", or "Inconclusive". Besides, cardiologists will report ECG wave's characteristics as well as any other possible diagnosis including "Superior ventricular tachycardia", "Ventricular tachycardia", "Atrial flutter", and "other types: other possible arrhythmias". In the case of uncertainties, a third cardiologist will be consulted, blinded for initial diagnoses.

The iECG recordings (test index) will be interpreted and reported in two different ways:

1. By using HealthKit Framework (Apple Watch and Apple iPhone applications): After a successful iECG recording with the Apple watch, iECGs will be transmitted by the ECG application to the iPhone. The Health App (Apple Inc., California) will receive, process and store the iECGs on the iPhone and will present one of the following results on the iPhone screen automatically: "Sinus rhythm", "High or low heart rate", "Atrial fibrillation", or "Inconclusive". Besides, the mean heart rate will be recorded, which will be automatically calculated by the Health App.
2. By cardiologist: All iECGs will be analyzed by 2 blinded cardiologists. They will report their findings in the following categorize: "Sinus rhythm", "High or low heart rate", "Atrial fibrillation", or "Inconclusive". Besides, they will report ECG wave's characteristics as well as any other possible diagnosis including "Superior ventricular tachycardia", "Ventricular tachycardia", "Atrial flutter", and "other types: other possible arrhythmias". In the case of uncertainties, a third cardiologist will be consulted, blinded for initial diagnoses.

ECG wave's characteristics: The following variables will be measured as the iECG and 12-lead ECG waves' characteristics. Three randomly chosen heartbeats will be considered to measure each wave or interval, and the mean of these 3 measurements will be used for statistical analysis.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Andreas Bollmann, MD, PhD; Phone Number: +49341865-0; Email: Andreas.Bollmann@helios-gesundheit.de
• Study Contact Backup: Name: Alireza Sepehri Shamloo, MD; Phone Number: +49341865-0; Email: Alireza.Sepehri-Shamloo@helios-gesundheit.de

Study Locations

• Germany
  • Leipzig, Germany, 04289
    • Recruiting
    • Andreas Bollmann
    • Contact: Andreas Bollmann, MD, PhD; Email: andreas.bollmann@helios-gesundheit.de
    • Contact: Alireza Sepehri Shamloo, MD; Email: Alireza.Sepehri-Shamloo@helios-gesundheit.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All individuals who had been admitted to the Department of Electrophysiology, Leipzig Heart Center

Description

Inclusion Criteria:

• Patients aged≥22 years at the time of eligibility screening will be included.
• Patients with known cardiac arrhythmias; i.e. AF before and after cardioversion, hemodynamically stable Bradycardias, SVT and VT during EP procedures and implants can also be included

Exclusion Criteria:

- Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients suspected with Cardiac Arrhythmia; iECG + 12-lead ECG recording in patients suspected with any type of cardiac arrhythmias at the time of recruitment	Device: iECG recording; iECG tracings will be recorded simultaneously, starting and ending at the same time as the standard 12-lead ECG, using the built-in sensors of a smart watch (Apple Watch Series 4) with the ECG application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Level of agreement between the cardiologist's interpretations of the 12-lead ECG and the ECG App interpretation results	Baseline
Level of agreement between the cardiologist's interpretations of the 12-lead ECG and iECG	Baseline
Level of agreement between the cardiologist's interpretations of the iECG and the ECG App interpretation results	Baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants that remain in arrhythmia diagnosis, from the positive diagnosis from the iECG to the performed 12-lead ECG	Baseline
Proportion of interpretable and non-interpretable iECGs	Baseline
Sensitivity and specificity of screening tests for cardiac arrhythmias identification using: cardiologists interpretation of iECG (index test) and 12-lead ECGs (reference test)	Baseline
Sensitivity and specificity of screening tests for cardiac arrhythmias identification using: ECG App interpretation results (index test) and 12-lead ECGs (reference test)	Baseline

Collaborators and Investigators

• Sponsor: Leipzig Heart Institute GmbH
• Collaborators: Heart Center Leipzig - University Hospital
• Investigators: Study Chair: Andreas Bollmann, MD, PhD, Heart Center Leipzig at University of Leipzig, Leipzig Heart Institute, Germany

Publications and helpful links

General Publications

• Behzadi A, Sepehri Shamloo A, Mouratis K, Hindricks G, Arya A, Bollmann A. Feasibility and Reliability of SmartWatch to Obtain 3-Lead Electrocardiogram Recordings. Sensors (Basel). 2020 Sep 7;20(18):5074. doi: 10.3390/s20185074.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Arrhythmias, Cardiac; Cardiovascular App; Rhythm monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: 2019-0157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes