S-ICD® System IDE Clinical Study

Inclusion Criteria

• For patients without an existing transvenous device
• Patient meets Class I, Class IIa or Class IIb indications/recommendations for ICD implantation per the current published guidelines at the time of enrollment
• For patients with an existing transvenous device
• Patient requires replacement or revision of an existing implanted transvenous ICD system
• Age is ≥ 18 years
• An appropriate pre-operative ECG per template provided

Exclusion Criteria

• Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study.
• Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study.
• Participation in any other investigational study without prior written consent from the study sponsor.
• Patients with a serious medical condition and life expectancy of less than one year.
• Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing, unless the patient is not a candidate for a transvenous ICD system.
• Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant.
• Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing.
• Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with an estimated GFR ≤ 29.