Aurora St. Luke’s Medical Center in Milwaukee is the first site in Wisconsin to implant a new investigational wireless, or leadless, pacemaker.
The procedure was part of an international clinical trial that will evaluate the safety and effectiveness of the AveirTM Dual-Chamber leadless pacemaker system. Currently, there are no dual-chamber leadless devices approved for use in the U.S.
Unlike traditional pacemakers, leadless pacemakers are fully self-contained and do not require the use of wires placed in the heart to deliver electrical pulses that help control the heart’s rhythm. Leadless pacemakers also utilize a smaller generator, removing the need for a large battery pack to be implanted in the chest.
“By eliminating the need to implant a large generator and connecting wires, leadless pacemakers – implanted through a minimally invasive procedure using a catheter guided through the body’s blood vessels – also eliminate the need for extensive surgery and could potentially reduce the risk of complications associated with traditional pacemakers,” said Mohammad Mortada, MD, Advocate Aurora Research Institute’s principal investigator for the study. “Patients will have no visible scar and no lump on the chest from the implant of a generator, which allows for improved patient comfort and reduced activity restrictions.”
More than 80% of patients in need of permanent pacemakers require dual-chamber devices that can detect and coordinate the pumping action in both the heart’s atrium and ventricle. However, only single-chamber leadless pacemaker systems are commercially available in the U.S.
“Previous studies have shown that nearly 10% of people who received traditional dual-chamber pacemakers experienced complications within two months, and many of them were related to the device’s pacing leads, which are the wires that carry electrical signals from the generator to the heart,” said Laura Wrona, MSN, director of cardiovascular clinical trials research. “Advocate Aurora Research Institute is proud to participate in research such as this that fills a clear clinical need for our patients.”
Researchers plan to enroll up to 550 participants in the study at sites around the world and will follow participants for up to five years after the implantation of their device.
The study, “Aveir DR i2i Study,” is sponsored by Abbott Medical, manufacturer of the study device.
To learn more about Advocate Aurora’s research, visit aah.org/research.