Surface ECG Signal Recording for the Implantable Subcutaneous String

Status Completed

Clinical Trial Summary

Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and discrimination of supra-ventricular arrhythmia of the algorithm,m compared to the expert.

Clinical Trial Description

cutaneous ECG electrodes positioned near the sternum and on the midaxillary line, at the approximate positions of the ISSD sense electrodes, are used to record patients undergoing Defibrillation Threshold (DFT) studies or Electrophysiology (EP) studies of different types. Two separate copies of the recordings undergo parallel and separate analysis: one is sent to an expert Electrophysiologist for determination and classification of arrhythmia events of at least 5 seconds and at least 170 beats per minute. the other is fed to the ISSD detection algorithm, with a low cutoff rate of 170 beats per minute. the results are compared to establish the accuracy of the detection algorithm and the rate of false detection / classification of arrhythmia events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03408951
Study type	Observational
Source	NewPace Ltd
Contact
Status	Completed
Phase
Start date	March 2, 2017
Completion date	December 5, 2018

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Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms