Angel Medical Systems ALERTS Study - Purpose

Clinical studies show that most myocardial damage occurs within the first two hours after coronary occlusion.   The ALERTS trial 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.

The objective of the ALERTS Study is to demonstrate the safety and effectiveness of an experimental device called the AngelMed Guardian® system.

The device was developed to help reduce the time it takes patients to get to the emergency room when they have a heart attack.  It works by monitoring the heart’s electrical signal for rapid changes in ST segment elevation, which may indicate the patient is starting to have a heart attack.

If the AngelMed Guardian system detects an abnormality in the heart signal, it will warn her or him to seek immediate medical care. The AngelMed Guardian system can also warn the patient if it encounters problems that prevent it from working properly.  In these situations, the patient will be alerted to visit their physician for an evaluation of the device.

The components of the AngelMed Guardian system are:

• A small device implanted under the skin (known as the AngelMed Guardian IMD)
• An endocardial lead inserted into the right ventricle and a lead adapter
• A pager-sized portable external alarm device (known as the EXD)
• A laptop computer used to program the device. 

The AngelMed Guardian system is a diagnostic monitor that will be implanted under the skin in the upper left side of the chest.  It will register the heart’s electrical signal (or "electrogram") using a small wire positioned inside the heart (similar to a pacemaker). 

Once implanted, it will continuously monitor the heart’s signal for anything unusual.  If the monitor detects an abnormality, it will alert the patient to seek medical attention by vibrating gently - similar to a cell phone vibration.  It will also send a signal to the EXD, which will then start beeping.  The EXD also will flash a small light to indicate what kind of alarm is being signaled.

Even though the AngelMed Guardian system is implanted and looks similar to a pacemaker, the use and implantation of the AngelMed Guardian system is considered experimental.