Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arrhythmia, Cardiac
- Sponsor
- NewPace Ltd
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- successful recording of Electrocardiogram (ECG) from a patient containing arrhythmia
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Candidate for ICD implantation
- •Candidate for EP study
- •Candidate for 24 hour holter monitor recording
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
successful recording of Electrocardiogram (ECG) from a patient containing arrhythmia
Time Frame: immediate
recorded Electrocardiogram (ECG) of patients with as many arrhythmia events as possible, preferably tachy-arrhythmia events such as fast VT, flutter or VF