Medical Professionals The ALERTS Clinical Study

The ALERTS Clinical Study

Study Overview

The ALERTS study design provides a clinical environment to test the efficacy of a device that may significantly reduce time to treatment and thus may decrease heart muscle damage and improve survival rates related to major cardiac events. After completing a Phase One study in the US, the AngelMed Guardian System is presently being tested in the ALERTS pivotal study. The ALERTS study is a prospective, randomized multicenter study with FDA approval for 100 centers and 1020 subjects with a high-risk of having a heart attack. All subjects have data collection and analysis enabled from the onset, however, subjects are randomized 1:1 for patient alerting ON or OFF for the first 6 months. After the initial 6 month period, patient alerting is enabled for the control group. All subjects will be followed until study closure.

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Primary Objectives

The following are the safety and efficacy endpoints for the study.

  • Safety: greater than 90% of subjects are free from system related complications at six months post-programming
  • Efficacy: The Guardian System reduces the composite of:
    • Cardiac or unexplained death
    • New Q-wave MI
    • Time to door > 2 hours for a thrombotic coronary occlusion event when compared with subjects without alerting for rapidly progressive ST shift events. Measured from the time the device detects a rapidly progressive ST shift event to time of arrival at a medical facility.

Patient Population

Historically, AngelMed has experienced a patient sceening to qualification rate of 20%, ie, 1 in 5 patients screened qualifies for study inclusion. Check our detailed lists of inclusion and exclusion criteria.

ALERTS Trial Site Locations

Click a state for a list of ALERTS locations.

Please note that new sites continue to open.

Get Involved In The ALERTS Study

For additional information on the ALERTS clinical study, please visit the Clinical Trials website of the US National Institutes of Health, or contact:

David Keenan
Vice President, Clinical & Regulatory Affairs
Angel Medical Systems
1163 Shrewsbury Ave., Suite E
Shrewsbury, NJ 07702
(732) 542-3350
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Caution: Investigational Device. Limited by United States law to investigational use.