Arrhythmia, Cardiac
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERrecorded patients
No intervention applied, only recording of cutaneous ECG signal from specific points on the torsi
Sponsors
NewPace Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Healthy volunteers
No
Inclusion criteria
* Candidate for ICD implantation * Candidate for EP study * Candidate for 24 hour holter monitor recording
Exclusion criteria
* age\<18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| successful recording of Electrocardiogram (ECG) from a patient containing arrhythmia | immediate | recorded Electrocardiogram (ECG) of patients with as many arrhythmia events as possible, preferably tachy-arrhythmia events such as fast VT, flutter or VF |
Countries
United States
Outcome results
None listed