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.
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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