An observational study in Tachyarrhythmia and Arrhythmias, Cardiac, sponsored by NewPace Ltd. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-21.
Sponsored by NewPace Ltd · Observational
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.
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.
Patients with high chance of having a cardiac tachyarrhythmia
Exclusion Criteria:
Patients requiring Intracardiac defibrillator (ICD) implantation or Defibrillation Test (DFT) or Electrophysiology (EP) study with high probability of supra ventricular tachyarrhythmia.
Other: Recording
The patient cutaneous ECG is recorded, to later be comparatively analysed by an expert and by the ISSD detection algorithm
ISSD algorithm detection rates
Calculation of the ISSD algorithm detection and classification rates, compared to an EP expert analysis of the ECG traces
Time frame: through study completion, expected at 15 months
Plan to share: No
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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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