Aurora St. Luke’s Medical Center in Milwaukee is the first site in Wisconsin participating in a post-market clinical trial evaluating a device designed to reduce the risk of stroke after a noninvasive heart valve replacement procedure.
The trial, “PROTECTED TAVR: Stroke protection with Sentinel during transcatheter aortic valve replacement,” will study how well Boston Scientific Corporation’s Sentinel® Cerebral Protection System reduces the risk of stroke for participants with aortic valve stenosis within 72 hours of undergoing a transcatheter aortic valve replacement (TAVR) procedure.
“The Sentinel Cerebral Protection System is used as a cerebral protection device to capture embolic material, like pieces of calcium or plaque, while performing transcatheter aortic valve procedures in order to reduce ischemic injury to the brain,” said interventional cardiologist Suhail Allaqaband, MD, Advocate Aurora Research Institute’s principal investigator for the study.
Although the TAVR procedure and its associated devices have revolutionized heart valve replacements, researchers reported rates of major stroke between 3% and 7% for first generation TAVR devices.
“As cardiologists have become more familiar with the devices and procedure and as the devices themselves have improved, we have lowered but not entirely eliminated the risk of stroke during TAVR,” Dr. Allaqaband said.
Clinicians have turned to cerebral embolic protection devices (CEPDs), such as the Sentinel system, to potentially further reduce the risk of post-TAVR neurological damage.
Previous clinical trials have directly investigated the safety and efficacy of CEPDs and demonstrated positive results. During one of those previous studies, the pivotal SENTINEL study, the Sentinel system demonstrated its ability to capture and remove embolic debris at a high frequency. Based on these observations, the U.S. Food and Drug Administration (FDA) approved the Sentinel system for use as a cerebral protection device in TAVR. However, the effectiveness of the Sentinel system at reducing stroke risk after TAVR requires additional study, prompting the creation of the PROTECTED TAVR trial.
“Even though the FDA deemed certain CEPDs safe for use during TAVR procedures, there is often still more we can learn about a treatment even after it has been approved,” said Nina Garlie, PhD, interim vice president for the Research Institute.
Study participants will be monitored by research staff for 72 hours or until hospital discharge, whichever comes first. Investigators plan to enroll up to 3,000 participants.
Advocate Aurora Research Institute is a leader in TAVR-related clinical trials, contributing to its first such study eight years ago. Aurora St. Luke’s TAVR team has now performed more than 2,500 TAVR procedures.