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

Completed

• Conditions: Arrhythmias, Cardiac; Tachyarrhythmia

• Registration Number: NCT03408951
• Lead Sponsor: NewPace Ltd

Brief 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.

Detailed 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 Timeline

• Study Start: 2017-03-02
• Status Verified: 2018-01
• Study First Submitted: 2018-01-16
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-24
• Primary Completion: 2018-12-05
• Study Completion: 2018-12-05
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• candidate for ICD implantation
• candidate for an ICD DFT study
• candidate for an EP study

Exclusion Criteria

• age <18

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ISSD algorithm detection rates	through study completion, expected at 15 months	Calculation of the ISSD algorithm detection and classification rates, compared to an EP expert analysis of the ECG traces

Trial Locations

Locations (1)

St Francis Hospital Heart Center; 🇺🇸 Roslyn, New York, United States