NCT01424722

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

ST Monitoring to Detect ACS Events in ICD Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,258 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices	Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.

Timeline

• Start date: 2011-08-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2011-08-29
• Last updated: 2021-01-28
• Results posted: 2021-01-28

Locations

97 sites across 1 country: United States

Regulatory

• FDA-regulated device study