The trial aims to demonstrate the safety and efficiency of a leadless II pacemaker system in patients with abnormal heart rhythm
Scottsdale, Ariz., MARCH 22, 2021 - HonorHealth, a leading community healthcare system serving 1.6 million people in the greater Phoenix area, and HonorHealth Research Institute announced today that the very first patient in the U.S. was implanted with the Abbott Medical Device leadless pacemaker technology as part of The LEADLESS Pacemaker IDE (Leadless II) clinical research study. Unlike traditional pacemakers, the leadless pacemaker does not require the physician to make an incision to implant the device or insulated wires known as leads, which deliver electrical energy to the heart. With this innovation, the device is implanted directly into the heart’s lower right chamber via a minimally invasive catheter-based procedure, eliminating the need for cardiac leads.
This first trial participant in the U.S. was implanted with the leadless pacemaker system at HonorHealth as part of a clinical study with HonorHealth Research Institute and is not commercially available to the public. The trial explores the safety and effectiveness of the leadless pacemaker in patients with slow heart rates or irregular heart rhythms.
Patients with heart arrhythmias have a heart condition where their heart either beats too fast, too slow, too early or overly irregular. People who experience a slower-than-average heart rate (bradycardia) may receive a pacemaker to restore a more regular heart rate. While leadless pacing systems work like traditional pacemakers to regulate heart rate, they may offer a less restrictive recovery period and reduce implant complications. The device has also been designed to be retrieved when it needs to be replaced or if the patient’s therapy needs to change.
Rahul N. Doshi, MD, FHRS, FACC, chief of complex arrhythmia management at HonorHealth and principal investigator for this study states, “Not only is this the first leadless pacemaker that is designed to be removable, if needed, for replacement, it is the first step to develop a fully leadless dual chamber pacemaker.”
The study will enroll 200 patients at 80 medical site locations around the world. Patients interested in this innovative study must be 18 years of age or older and do not need to live in Arizona to participate in this study but must meet the required study criteria. More information about this study and general information about participating in clinical trials at HonorHealth Research Institute can be found at ClinicalTrials.gov or by contacting the cardiovascular research team by calling 480-323-1046 or emailing email@example.com.
HonorHealth is a non-profit, local community healthcare system serving an area of 1.6 million people in the greater Phoenix area. The network encompasses six acute-care hospitals, an extensive medical group, outpatient surgery centers, a cancer care network, clinical research, medical education, a foundation and community services with approximately 12,800 employees, 3,500 affiliated providers and 3,100 volunteers. HonorHealth was formed by a merger between Scottsdale Healthcare and John C. Lincoln Health Network. HonorHealth’s mission is to improve the health and well-being of those we serve. Learn more at HonorHealth.com
About HonorHealth Research Institute
HonorHealth Research Institute is helping shape the future of medicine. We're finding cures and improving treatments in gene therapy, early drug/device development, early detection and prevention of disease. Through our clinical trials and applied research, we’ve given hope and improved patients’ lives from all 50 states and 28 different countries around the globe. Our advanced technologies and cutting-edge treatment options are introducing tomorrow’s cures today. For more information on cardiovascular clinical trials call 480-323-1046 or email firstname.lastname@example.org or learn more at HonorHealth.com/research. Follow HonorHealth Research Institute on Facebook, LinkedIn and Twitter @HRInstitute_AZ.