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OpenTrials
Completed

NCT Number: NCT03662802

Development of a Novel Convolution Neural Network for Arrhythmia Classification

Identifying the correct arrhythmia at the time of a clinic event including cardiac arrest is of high priority to patients, healthcare organizations, and to public health. Recent developments in artificial intelligence and machine learning are providing new opportunities to rapidly and accurately diagnose cardiac arrhythmias and for how new mobile health and cardiac telemetry devices are used in patient care. The current investigation aims to validate a new artificial intelligence statistical approach called 'convolution neural network classifier' and its performance to different arrhythmias diagnosed on 12-lead ECGs and single-lead Holter/event monitoring. These arrhythmias include; atrial fibrillation, supraventricular tachycardia, AV-block, asystole, ventricular tachycardia and ventricular fibrillation, and will be benchmarked to the American Heart Association performance criteria (95% one-sided confidence interval of 67-92% based on arrhythmia type). In order to do so, the study approach is to create a large ECG database of de-identified raw ECG data, and to train the neural network on the ECG data in order to improve the diagnostic accuracy.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Clinic

San Diego, California, 92037, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All ECG data compiled from 12-lead ECG, single, and multiple lead databases

Exclusion criteria

  • None

Treatment and study plan

Neural Network Classifier

Other

The convolutional neural network is configured to receive an electrocardiogram segment as an input and to generate an output indicative of whether the received electrocardiogram segment represents a cardiac arrhythmia. No specific features of the electrocardiogram are identified to the convolutional neural network, and the received electrocardiogram segment is not filtered, transformed, or processed prior to reception by the algorithm. The algorithm is trained in a similar manner - the electrocardiogram segments are the sole input to the convolutional neural network.

Primary outcomes

  1. Diagnostic Accuracy

    Time frame: 1 YEAR

    American Heart Association ECG Performance Criteria

Sponsors and collaborators

Lead sponsor

Scripps Clinic

Other

Registry information

Official study title

Development of a Novel Convolution Neural Network for Arrhythmia Classification for Shockable Cardiac Rhythms

Acronym: AI-ECG

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 7, 2018
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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