This is a prospective, non-randomized, multicenter, pivotal IDE study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in the Fortify® ST, Fortify Assura® ST, and Ellipse® ST family of devices, as well as any future St Jude Medical devices with the same ST Monitoring Feature capabilities. Effectiveness of the device will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to detect clinical events. In addition, safety of the ST Monitoring Feature will be evaluated by demonstrating a low percentage of patients with false positive events.
This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in St Jude Medical ICD systems.