Arrhythmias, Cardiac, Tachyarrhythmia
Conditions
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.
Interventions
OTHERRecording
The patient cutaneous ECG is recorded, to later be comparatively analysed by an expert and by the ISSD detection algorithm
Sponsors
NewPace Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* candidate for ICD implantation * candidate for an ICD DFT study * candidate for an EP study
Exclusion criteria
* age \<18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed