AngelMed Guardian® System for Acute Coronary Syndrome

This trial tests the AngelMed Guardian® System, a device designed to assist patients with serious heart issues, such as a heart attack or unstable angina, by detecting and warning of potential future heart events. The goal is to evaluate the device's effectiveness in real-life settings with patients at high risk for additional heart problems. Ideal participants have experienced a high-risk heart condition and have conditions like diabetes or kidney problems. Participants should live near a hospital to quickly respond to any alerts from the device. As a Phase 3 trial, this study serves as the final step before FDA approval, offering participants a chance to contribute to potentially life-saving advancements.

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Research has shown that the AngelMed Guardian® System has been tested for safety in individuals with heart problems, particularly those with acute coronary syndrome (ACS). This system alerts patients to changes in their heart's electrical activity that might indicate a heart attack.

Studies have found that the Guardian System accurately detects these changes, often before patients notice any symptoms. The FDA has approved this early warning system, confirming it has passed thorough testing for safety.

The system is generally well-tolerated, with no major safety concerns reported. Some users might experience minor discomfort or irritation at the device's placement site. However, serious problems related to the system itself are uncommon.

The AngelMed Guardian® System is unique because it acts as an internal alert system for patients who have had acute coronary syndrome (ACS) events. Unlike traditional treatments like medications or lifestyle changes that manage symptoms or risk factors, this device is implanted and continuously monitors the heart's electrical signals. Researchers are excited because it can potentially warn patients of a heart attack before symptoms even start, allowing for quicker medical intervention and possibly better outcomes. This proactive approach could be a game-changer in preventing recurrent ACS events.

Research has shown that the AngelMed Guardian® System, which participants in this trial will receive, can detect heart blockages before patients notice any symptoms. This system alerts users to possible heart problems, enabling faster medical intervention. Early detection of heart issues, such as heart attacks, can improve patient outcomes both in the hospital and afterward. The FDA has recognized the system's ability to signal the earliest signs of heart problems, highlighting its potential to save lives by reducing the time it takes for patients to receive care.¹³⁴⁵⁶