Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient comfort will be assessed as will cosmetic outcome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
6
Auckland City Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Number of Participants With a Successful Induced Ventricular Fibrillation Conversion
Sustained ventricular fibrillation induced by the investigator is successfully converted. A successful conversion was defined as two consecutive successful shocks out of four attempts with either standard polarity or with reverse polarity.
Time frame: 30 days
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