Trinity Health First in the Midwest to Implant Next-Generation Leadless Pacemaker as Part of FDA Pivotal Trial
August 11, 2026
FOR IMMEDIATE RELEASE
Media Contact: Von Lozon
Pager: (248) 725-2400
von.lozon@trinity-health.org
Photo: (L to R) Jihn Han, M.D. and Mohammad-Ali Jazayeri, M.D.
ANN ARBOR, Mich. (Aug. 11, 2026) – Trinity Health Ann Arbor is the first hospital in Michigan and the Midwest to implant an investigational next-generation leadless pacemaker as part of an FDA Investigational Device Exemption (IDE) clinical study evaluating advancements in cardiac pacing technology.
The procedure was successfully performed on Aug. 6, 2026, at Trinity Health Ann Arbor and marks an important milestone in bringing innovative cardiovascular therapies to Michigan patients. The investigational technology is designed to provide leadless pacing while enabling the heart's upper and lower chambers to work together more naturally through advanced sensing capabilities. The study is evaluating the technology’s safety, pacing performance and impact on patients’ quality of life.
“Advances in electrophysiology are happening at a remarkable pace, and we’re proud to be at the forefront of it all, offering innovative therapies that can improve both quality of life and longevity for our patients,” said Jihn D. Han, M.D., electrophysiologist and medical director of the Electrophysiology Lab at Trinity Health Ann Arbor. “Being selected as the first site in Michigan for this study reflects our commitment to providing patients access to promising new therapies and advancing the science of cardiovascular medicine.”
Leadless pacemakers represent a significant advancement in cardiac rhythm management because they eliminate the need for traditional pacing leads and a surgically created device pocket along the chest wall. This helps recipients by reducing long-term lead-related complications, minimizing device-related infections, and enhancing patient comfort.
The ongoing multicenter study is enrolling patients at leading institutions around the world to evaluate the performance of this next-generation leadless pacing system in real-world clinical settings. A total of 325 people will be enrolled in centers from the U.S., Europe, and Asia.
“Traditional pacemakers have improved the lives of millions of people, and leadless pacing has further advanced the field by offering a less invasive alternative,” said Mohammad-Ali Jazayeri, M.D., electrophysiologist and medical director of the Cardiac Device Clinic at Trinity Health Ann Arbor. “This study explores a technology that may expand the capabilities of leadless pacing by improving coordination between the upper and lower chambers of the heart. We are excited to contribute to this research and offer eligible patients access to the most advanced treatment options.”
Trinity Health Ann Arbor has a long history of participating in leading cardiovascular clinical trials and making emerging therapies accessible to patients close to home. The hospital's cardiac electrophysiology team specializes in the diagnosis and treatment of heart rhythm disorders and offers a full range of advanced procedures and technologies.
For more information about Trinity Health Ann Arbor's cardiovascular services, visit https://www.trinityhealthmichigan.org/services/cardiovascular. For more information on the clinical trial, go to https://clinicaltrials.gov/study/NCT07118358.
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About Trinity Health Michigan
Trinity Health Michigan is a leading health care provider and one of the state’s largest employers. With more than 25,000 full-time employees, Trinity Health Michigan is composed of nine hospitals located in Ann Arbor, Chelsea, Grand Haven, Grand Rapids, Livingston, Livonia, Muskegon, Oakland and Shelby, and two medical groups. The health system has 1,459 employed physicians and a medical staff of more than 5,766 providers. With operating revenues of $5.16 billion, Trinity Health Michigan returns $357 million back to their local communities each year. Together with numerous ambulatory care locations, home health and hospice agencies and 16 senior living communities owned and/or operated by Trinity Health, Trinity Health Michigan provides the full continuum of care for Michigan residents.
As members of Trinity Health, our services are connected to the national network of one of the largest health systems in the country. That means more access to experts, research, facilities, support, clinical trials and leading technology.