The ALERTS study design provides a clinical environment to test the efficacy of the AngelMed Guardian System, which is designed to significantly reduce time to treatment and thus may decrease heart muscle damage and improve survival rates related to major cardiac events. ALERTS is a pivotal study that succeeded an earlier Phase One safety study in the US.
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. Having achieved patient enrollment goals, the study is closed to new enrollments; still, all subjects will be followed through study closure. Upon joining the study, all subjects were enabled for data collection and analysis; however, only the treatment group subjects had the alerting function turned on. Alerting was intially disabled for the control subjects, but was later enabled after each subject completed six months in the study. Study subjects were randomized 1:1 between treatmant and control groups.
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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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Please note the ALERTS study is currently under review by the FDA as part of AngelMed's Premarket Approval (PMA) submission for the AngelMed Guardian System. The study is no longer enrolling patients.
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 788 Shrewsbury Ave., Suite 2144Tinton Falls, NJ 07724(732) 665-6895