Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/19/2018 |
| Start Date: | January 2016 |
| End Date: | June 2017 |
Record cutaneous Electrocardiogram (ECG) data from positions corresponding to the expected
subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using
existing, approved ECG recording devices.
subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using
existing, approved ECG recording devices.
2 electrodes places near the sternum and 2 near the midaxillary line, simulating the expected
positions of Implantable Subcutaneous String Defibrillator (ISSD) sense electrodes. reference
ECG electrodes are also attached (in most cases). Approved ECG recording devices are used to
record the signal continuously: During an EP session (different types) a bedside recorder,
and a holter monitor is used during holter recordings. Ep session recordings are performed in
order to capture different types of arrhythmia, and holter recordings are performed to
observe changes in ECG morphology due to activity, position changes, circadian cycles etc.
The data is saved and used in the development of the ISSD.
positions of Implantable Subcutaneous String Defibrillator (ISSD) sense electrodes. reference
ECG electrodes are also attached (in most cases). Approved ECG recording devices are used to
record the signal continuously: During an EP session (different types) a bedside recorder,
and a holter monitor is used during holter recordings. Ep session recordings are performed in
order to capture different types of arrhythmia, and holter recordings are performed to
observe changes in ECG morphology due to activity, position changes, circadian cycles etc.
The data is saved and used in the development of the ISSD.
Inclusion Criteria:
- Candidate for ICD implantation
- Candidate for EP study
- Candidate for 24 hour holter monitor recording
Exclusion Criteria:
- age<18
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