Lourdes Cardiology Services Announces ALERTS Pivotal Study for Implantable Cardiac Monitor and Alert System
Wednesday, August 15, 2012
Lourdes Cardiology Services recently announced its participation in the ALERTS Pivotal US trial for the AngelMed Guardian implantable cardiac monitor and alert system, which prompts patients of a heart problem through a unique vibration and paging system.
The objective of the ALERTS Pivotal Study is to provide an assessment of the safety and effectiveness of the AngelMed Guardian System. Our Lady of Lourdes Medical Center is among the first medical facilities in the country to participate in the trial.
The AngelMed Guardian system is comprised of an internal implantable device, a standard pacemaker lead and an external telemetry device and is designed to track significant changes in the heart's electrical signal. Once a change is detected, patients are alerted to seek immediate medical attention. A programmer is also used to wirelessly program and retrieve data stored in the implantable device.
When a problem occurs, the patient is able to feel a vibration through his or her chest and also receives an alert via page. One vibration signals the patient to see a physician while five vibrations alerts the patient to go to the emergency department.
This device is expected to reduce the time it takes patients to get to the emergency room by cautioning them immediately instead of relying on instinct to go.
"If the Guardian system proves to be effective in early detection and warning of potentially life-threatening heart conditions, we may be able to shift the paradigm for early treatment at the onset of heart attacks," said Devender N. Akula, MD, FACC, principal investigator of the study. "We are excited to participate in this important clinical trial."
According to American Heart Association statistics, in 2008, one out of every six deaths in the US was attributable to coronary heart disease. Each year, an estimated 785,000 Americans will have a new coronary attack, and 470,000 will have a recurrent attack. Additionally, 195,000 silent first myocardial infarctions occur each year.
One study participant, a 43-year-old South Jersey man, suffers from coronary heart disease.
For years, he neglected his health, living a mostly sedentary life and consuming unhealthy food. When his weight reached an all-time high of 300 pounds a year ago, he decided it was time to make a lifestyle change. He began working out 5 to 6 days a week and lost 30 pounds. After taking a short time off from his rigorous exercise routine, he attempted to get back on the treadmill and could not last for more than 5 minutes.
"I couldn't breathe and I felt extremely fatigued," the participant said. "My doctor advised me to see a cardiologist, and after failing a stress test, I was scheduled for a cardiac catheterization. It was determined that I had several blocked arteries. One artery was 90 percent blocked and several others were pretty bad, as well."
After receiving a stent and balloon angioplasty, he was informed of the AngelMed study underway at Lourdes. He decided to sign up for it.
The study participant said before receiving the AngelMed System, he "constantly worried, is it my time?"
"When someone has a heart attack, it is typically the result of a blood clot closing one of the three major coronary arteries. When this happens, there is a shift in the ST segment of the heart signal caused by the electrical difference between the portion of the heart muscle fed by the closed artery and the rest of the heart that is still receiving oxygen," said AngelMed CEO, David Fischell, Ph.D. "The ALERTS trial is designed to test the Guardian's ability to detect this electrical shift in a clinical setting and then provide an early warning to patients that could potentially save their lives."
Fortunately for the participant, he has not been alerted so far, but says he feels "less anxiety" knowing that that the device will alert him if something is wrong.
"I have more confidence in what I am doing now and don't worry as much about every little ache and pain. The device gives me peace of mind."
Forward Looking Statements: Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the Company's products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.
For media inquiries, please contact Lauren Markin at Markinl@lourdesnet.org or (856) 705-1375.