Researchers at NYU Langone Medical Center in the Department of Cardiothoracic Surgery announced they are co-leading a new clinical study evaluating the next-generation Medtronic CoreValve EvolutR System. The trial will evaluate the safety and effectiveness of the novel investigational self-expanding valve used during transcatheter aortic valve replacement (TAVR) surgery. The first patient was implanted with the device this month.
Mathew R. Williams, MD, recently joined NYU Langone Medical Center as the chief of Adult Cardiac Surgery and director of Interventional Cardiology and Structural Heart Center, and is the co-primary investigator for the study. He brings with him a history of both expertise in cardiac surgery and interventional cardiology, and investigating new surgical technology in both fields.
“We’re excited to be part of this large new trial testing an innovative technology that has the potential to advance the field of cardiac surgery. The new device is smaller and more maneuverable than the previous generation of transcatherer valves, which may allow the surgeon more flexibility during surgery,” he said. “This could be an advantage over previous generations of this device, and may have the potential to improve patient’s quality of life using minimally invasive techniques, which is always our main goal.”
Aortic stenosis is one of the most common and serious valve diseases, affecting up to an estimated 1.5 million people in the U.S. each year. It is a condition where the narrowing of the aortic valve restricts blood flow from the left ventricle of the heart to the aorta, and also affects the pressure in the left atrium. Symptoms of aortic stenosis can include feeling faint, weak, or lethargic, and if left untreated, the disease can lead to heart failure and even death.
The prospective CoreValve Evolut R Clinical Study will enroll up to 250 patients with severe symptomatic aortic stenosis who are considered at high risk for open-heart surgical aortic valve replacement, at 25 U.S. sites. The primary endpoints are all-cause mortality and disabling stroke at 30 days, as well as device success rate at 24 hours to seven days. Secondary endpoints include recapture success rate, when attempted, and hemodynamic performance.
Jeffrey J. Popma, MD, director of Interventional Cardiology at the Beth Israel Deaconess Medical Center and professor of medicine at Harvard Medical School, Boston, is co-primary investigator of the study.