Clinical Trials
Angel Medical Systems DETECT Feasibility Study
Overview
Approximately one million heart attacks occur in the United States each year; approximately 400,000 of these are fatal. Thus, heart attack remains one of the leading causes of death in the United States. One of the most important factors that determine how well a patient does following a heart attack is prompt treatment. The National Institute of Health recently published a brochure, “Act in Time to Heart Attack Signs”. The brochure says that people don't get to the hospital in time because they do not recognize the symptoms of a heart attack - instead, they take a “wait and see” approach. Currently, in the United States, the average time for the arrival of a person with a heart attack at an emergency room is 2.5 - 3.0 hours. Taking the "wait and see" approach makes it less likely that the patient will survive the attack. And if the patient does survive the attack, complications such as heart failure are more likely to occur - which results in more hospitalizations later, and a lower patient survival rate.
Purpose of this Study
The objective of the DETECT Feasibility Study is to provide a preliminary assessment of 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 that 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.
Description of the Guardian System
The components of the AngelMed Guardian system are:
- A pacemaker-sized device to be implanted under the skin (known as the AngelMed Guardian IMD)
- An endocardial lead and lead adapter
- A pager-sized portable external alarm device (known as the EXD – External Alarm Device)
- A laptop computer that will be used by the doctor 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 in the same manner as a pacemaker. It will register the heart’s electrical signal (or "electrogram") using a small wire positioned inside the heart (just like 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 underneath their skin - similar to a cell phone vibration. It will also send a signal to the EXD, which will then start beeping. Also, a light on the EXD will flash to indicate what kind of alarm is being signaled.
Even though the AngelMed Guardian system is implanted in the same manner and looks like a pacemaker, the use and implantation of the AngelMed Guardian system is considered experimental.
Potential Risks of Participation in the Clinical Study
Clinical trials involve risks and there may be side effects or adverse reactions to the device that may be unforeseeable. Implantation of the AngelMed Guardian system requires surgery and implantation of a lead into the heart; as with any type of surgery there are potential risks involved. All potential study participants will be given an informed consent form that describes all known risks. As with any new medical device, there may be other risks that are currently unknown. Prior to participation in this or any clinical study, it is important to discuss the clinical trial procedures, risks, and potential benefits of any procedure or operation in more detail with the physician at the clinical trial site.
Who is Eligible to participate?
Individuals who have presented with high-risk acute coronary syndromes as a result of coronary artery disease may be eligible for participation:
Inclusion Criteria
- Subjects (men or women) at least 55 years of age
- Subject has at least one of the following conditions:
- Diabetes (Type I or Type II)
- Low Ejection Fraction (EF < 0.40)
- Compromised renal function (Cr > 1.2 mg/dl)
- TIMI Risk Score > 3
- Presents with a high-risk acute coronary syndrome (STEMI or NSTEMI)
- Has already undergone coronary angiography and revascularization, if planned
- Has obtained medical care from a physician affiliated with the study hospital and lives in a geographic area in close proximity (within 30 minutes by EMS) to the study hospital
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