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

NCT01424722 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2258

Last updated 2021-01-28

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Michael Gibson, MD · Boston Clinical Research Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2017-06-30
Completion
2017-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01424722 on ClinicalTrials.gov