Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/26/2018 |
| Start Date: | March 2, 2017 |
| End Date: | June 2018 |
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.
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.
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.
Inclusion Criteria:
- candidate for ICD implantation
- candidate for an ICD DFT study
- candidate for an EP study
Exclusion Criteria:
- age <18
We found this trial at
1
site
Click here to add this to my saved trials
