With two clinical trial sites, Advocate Aurora Health contributed to a research study that led to the recent U.S. Food and Drug Administration (FDA) approval of a new device to treat people with atrial fibrillation (AFib) who are at risk for ischemic stroke.
The clinical trial evaluated the safety and efficacy of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder. Advocate Aurora Research Institute enrolled study participants at Advocate Christ Medical Center in Oak Lawn, Illinois, and Aurora St. Luke’s Medical Center in Milwaukee, which was the only site in Wisconsin to join the study.
The FDA granted approval for the device after the clinical trial found that the device offers immediate closure of the left atrial appendage (LAA) for patients with AFib, reducing their risk of stroke.
“The left atrial appendage is a small sac in the wall of the heart,” said electrophysiologist Jasbir Sra, MD, Aurora St. Luke’s principal investigator for the study. “Physicians are unsure of its true function, however, in patients with AFib, their irregular heartbeat can result in blood collecting in the left atrial appendage, where blood clots can form. If one of these clots is then pumped out of the heart and to the brain, it can cause a stroke.”
Physicians can prescribe blood-thinning medications to reduce the risk of a stroke for some patients, but for those who cannot take blood thinners long term, physicians may recommend occlusion, or closure, of the LAA.
AFib is the most common type of heart arrythmia, affecting 2.7 million Americans, and is associated with a five-fold increased risk of stroke, according to the American Heart Association.
The clinical trial found that the Amplatzer™ Amulet™ Left Atrial Appendage Occluder effectively provides complete and immediate closure of the LAA and demonstrated that patients do not need to take blood thinners following the minimally invasive procedure.
“The Amulet device furthers our ability to close complex left atrial appendage anatomy, and allows more patients to receive the benefits of left atrial appendage occlusion for the risk reduction of stroke,” said electrophysiologist William Spear, MD, Advocate Christ’s principal investigator for the study. “Advocate Aurora is proud to participate in cardiovascular clinical trials such as this that directly improve care of our patients.”
The study, “AMPLATZER™ Amulet™ LAA Occluder Trial (Amulet IDE),” was sponsored by Abbott, manufacturer of the device.
To learn more about Advocate Aurora’s research, visit aurora.org/research.