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Smartwatch iECG for the Detection of Cardiac Arrhythmias

2019-09-23 04:51:43 | BioPortfolio

Summary

This study aims to assess the feasibility and reliability of smartwatch 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 smartwatch 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 smartwatch (Apple Watch Series 4) with the ECG application.

Description

This diagnostic accuracy study is an investigator-initiated trial to evaluate the value of a smartwatch-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 smartwatch (Apple Watch Series 4) with the market version of the ECG application (Apple Inc., Cupertino, 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., Cupertino, 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 Design

Conditions

Arrhythmias, Cardiac

Intervention

iECG recording

Status

Not yet recruiting

Source

Leipzig Heart Institute GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-23T04:51:43-0400

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Medical and Biotech [MESH] Definitions

Any disturbances of the normal rhythmic beating of the heart or MYOCARDIAL CONTRACTION. Cardiac arrhythmias can be classified by the abnormalities in HEART RATE, disorders of electrical impulse generation, or impulse conduction.

A group of cardiac arrhythmias in which the cardiac contractions are not initiated at the SINOATRIAL NODE. They include both atrial and ventricular premature beats, and are also known as extra or ectopic heartbeats. Their frequency is increased in heart diseases.

Tumors in any part of the heart. They include primary cardiac tumors and metastatic tumors to the heart. Their interference with normal cardiac functions can cause a wide variety of symptoms including HEART FAILURE; CARDIAC ARRHYTHMIAS; or EMBOLISM.

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Unexpected rapid natural death due to cardiovascular collapse within one hour of initial symptoms. It is usually caused by the worsening of existing heart diseases. The sudden onset of symptoms, such as CHEST PAIN and CARDIAC ARRHYTHMIAS, particularly VENTRICULAR TACHYCARDIA, can lead to the loss of consciousness and cardiac arrest followed by biological death. (from Braunwald's Heart Disease: A Textbook of Cardiovascular Medicine, 7th ed., 2005)

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