Aurora St. Luke’s Medical Center in Milwaukee has joined a clinical trial studying a new potential replacement heart valve, continuing its long history of research into minimally invasive heart valve replacements.
The study will evaluate the safety and effectiveness of Boston Scientific Corporation’s ACURATE neo2™ Aortic Valve System in patients with severe symptomatic aortic stenosis who are candidates for transcatheter aortic valve replacement (TAVR).
“In people with severe aortic stenosis, the leaflets, or flaps, that make up the heart’s aortic valve become hard and stiff, preventing the valve from working properly, which puts excess strain on the heart and can lead to heart failure,” said interventional cardiologist Tanvir Bajwa, MD, Advocate Aurora Research Institute’s principal investigator for the study. “Fortunately, cardiovascular researchers, including our team at Aurora St. Luke’s, have advanced the field of minimally invasive TAVR procedures to the point where they are the standard of care for many patients, instead of potentially risky open heart surgery.”
TAVR is a minimally invasive procedure in which a team of cardiologists and cardiac surgeons insert the replacement aortic valve via a small tube called a catheter through a small incision in the femoral vein in the leg. The doctors then carefully thread the catheter, guided by imaging technology, through the body’s chain of blood vessels until it reaches the placement point in the heart, at which point the device is implanted and the catheter is removed.
“The Research Institute is a leader in TAVR-related clinical trials, contributing to its first such study nine years ago,” said Laura Wrona, MSN, director of cardiovascular clinical trials research. “Aurora St. Luke’s TAVR team has now performed more than 3,000 TAVR procedures, plus many other transcatheter valve replacement and repair procedures.”
This new clinical trial compares the ACURATE neo2™ Aortic Valve System to two TAVR devices already approved by the U.S. Food and Drug Administration for use in patients with aortic stenosis.
“Researchers want to determine if the ACURATE neo2 device’s features give it a performance advantage for participants in the clinical trial,” Dr. Bajwa said.
Participants in the study will be randomly assigned to receive the investigational device or one of the two control devices. Researchers plan to enroll 1,500 participants at sites across the U.S. and Canada.
The study, “ACURATE IDE: Safety and efficacy study of Acurate valve for transcatheter aortic valve replacement,” is sponsored by Boston Scientific Corporation, manufacturer of the study device.
To learn more about Advocate Aurora’s research, visit aurora.org/research.
About Advocate Aurora Research Institute
Advocate Aurora Research Institute is a not-for-profit, limited liability company of Advocate Aurora Health. Advocate Aurora has emerged as a national destination for patient-centered bench, translational and clinical research, and the Research Institute unifies the innovative research efforts throughout the health system. Advocate Aurora researchers focus on rapidly translating new discoveries from the scientist’s bench to the patient’s bedside and into the community we serve to improve options and outcomes that change not only the lives of individuals, but transform the health of populations.