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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The following are the safety and efficacy endpoints for the study.
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.
Click a state for a list of ALERTS locations.
Please note that new sites continue to open.
For additional information on the ALERTS clinical study, please visit the Clinical Trials website of the US National Institutes of Health, or contact:
David KeenanVice President, Clinical & Regulatory AffairsAngel Medical Systems 1163 Shrewsbury Ave., Suite EShrewsbury, NJ 07702(732) 542-3350