GAINESVILLE, Ga. — Northeast Georgia Heart Center (NGHC) in collaboration with Northeast Georgia Medical Center (NGMC) has enrolled its first patient in a new trial sponsored by St. Jude Medical. Northeast Georgia Heart Center is one of 200 nationwide centers participating in the ST Monitoring to Detect ACS (Acute Coronary Syndrome) Events in ICD Patients study, known as the Analyze ST trial. The trial will study the safety and effectiveness of a new feature in the device maker’s Fortify® ST implantable cardioverter defibrillator (ICD) system.
On Aug 15, the first patient in the state of Georgia was implanted with the Fortify® ST cardioverter defibrillator device by Joon Ahn, MD at Northeast Georgia Medical Center.
“We are very exciting to participate in a cutting edge trial of this magnitude. We believe this is an extraordinary opportunity to make a vitally important contribution to medical science that may ultimately lead to saving patients’ lives,” said Joon Ahn, MD, co-principle investigator, electrophysiologist with Northeast Georgia Heart Center.
More than half of patients experiencing a heart attack die before reaching a hospital. Even patients with stable coronary artery disease (CAD) are at high risk of having a life-threatening or potentially fatal coronary event. Additionally, 15 to 20 percent of patients who have had an ischemic event have recurrent events. As a result, CAD needs to be managed on an ongoing basis to avoid a more unstable or life threatening acute coronary event. Furthermore, approximately two thirds of ICD patients have cardiac ischemia (narrowing or blockage responsible for significantly obstructing the flow of blood to a patient’s heart muscle), with many more having risk factors for developing cardiovascular disease.
The ST monitoring feature in the Fortify ST ICD is designed to detect a coronary event, such as a heart attack, by monitoring changes in a specific section of the patient’s heartbeat – the ST segment. Changes in the ST segment have long been studied via surface electrocardiograms as a potential indicator of a heart attack. This unique feature adds a new diagnostic capability to the ICD system so that physicians can automatically monitor the ST segment from inside the body and on a continual basis. The Analyze ST study will determine if this diagnostic capability can provide detection of acute coronary syndrome events, and may provide important insights leading up to an event. The study will also provide key insights on the value of such a diagnostic feature in possibly reducing the event-to-treatment time and positively impacting patient outcomes.
As part of this new feature, a transmitter will provide updates to physicians who will then be able to remotely monitor their patients’ ST segment changes. The device can also alert the patient to a change in the ST segment, prompting them to seek medical attention.
“Demonstrating our commitment to improving patient’s lives and broadening research we are proud to participate in the Analyze ST trial,” says Salem Sayar, MD, principal investigator and electrophysiologist with Northeast Georgia Heart Center. “We recognize the potential this new feature has to help save lives and enhance the care we can provide to patients. We look forward to contributing to the study in a meaningful way.”
Earlier this year, St. Jude Medical received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to start its Analyze ST trial. The technology has been an available feature in St. Jude Medical ICDs in Europe since 2008, but this is the first trial to study the device’s use in the U.S. In all, more than 5,000 patients will participate in the study to evaluate the effectiveness and safety of the new ST monitoring feature.
For more information on the Analyze ST trial, visit www.sjm.com.