Study of the AngelMed GuardianSystem Implant in Adults at High Risk for Repeat Acute Coronary Syndrome Events

What this Trial Is About

This study involves patients who have had previous acute coronary syndrome ACS events and are at high risk for recurrent ACS. It aims to evaluate the AngelMed Guardian System, an implantable cardiac monitor that alerts patients to potential ongoing ACS events. The study will assess the devices diagnostic accuracy, physician compliance, patient compliance with alerts, and the adequacy of training programs for physicians and patients. Participants will be implanted with the AngelMed Guardian System and receive standard care, including an initial programming visit 7 to 14 days after implantation and follow-up visits every 6 months. The study is event-based and will continue until 314 adjudicated true or false positive ACS events have been collected. The device detects sustained ST segment changes and alerts patients to seek medical attention for potential ACS events, including asymptomatic ones. During the study, patients will have regular in-office visits for device programming and monitoring. Researchers will track the occurrence of ACS events, patient and physician responses to alerts, and the effectiveness of training programs. The main outcome measures include the devices positive predictive value and false positive rate. The study will last for approximately 3 years, with follow-up visits every 6 months until study completion or exit.

AngelMed Guardian® System PMA Post Approval Study