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OpenTrials
Completed

NCT Number: NCT03408951

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

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.

Completed

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Key information

Conditions

Tachyarrhythmia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Francis Hospital Heart Center

Roslyn, New York, 11576, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • age <18

Treatment and study plan

recording

Other

The patient cutaneous ECG is recorded, to later be comparatively analysed by an expert and by the ISSD detection algorithm

Primary outcomes

  1. ISSD algorithm detection rates

    Time frame: 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

Sponsors and collaborators

Lead sponsor

NewPace Ltd

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2018
Registry last updated
Aug 21, 2019

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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