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ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients — AnalyzeST  

Coronary Artery Disease Clinical Trial

Official title:
ST Monitoring to Detect ACS Events in ICD Patients

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01424722
Study type Interventional
Source Abbott Medical Devices
Contact
Status Terminated
Phase N/A
Start date August 2011
Completion date June 2017
View Details
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