Washington, D.C., Jan. 19, 2016 - MedStar Heart & Vascular Institute at MedStar Washington Hospital Center will be the first in the nation to launch a clinical trial, evaluating the use of a minimally invasive procedure to replace narrowed heart valves in patients who are considered at low risk for death from surgery. The Food and Drug Administration granted an Investigational Device Exemption, which allows MedStar Heart to use the investigational device in a research setting, and to enroll these patients into the study, which is starting this month.
For decades, traditional open-heart surgery has been the gold standard for treating patients with severe aortic stenosis, an abnormal narrowing of the aortic valve in the heart. The only effective treatment is to replace the heart valve. The procedure, called TAVR, for transcatheter aortic valve replacement, is currently FDA approved for patients who are inoperable or too high-risk to undergo the open surgical procedure.
With TAVR, instead of opening the chest, physicians insert a new valve using a catheter threaded into the heart through a small incision in the groin or chest wall.
Trials are currently underway to investigate the use of TAVR in patients with intermediate surgical risk. However, the new study at MedStar Heart will be the first in the U.S. to investigate whether the results of TAVR in these patients are comparable to a lower-risk population.
"We appreciate the FDA's trust in our ability to conduct this important investigation of TAVR and its safety and efficacy in the low-risk population," said Ron Waksman, MD, lead investigator of the study and director of Cardiovascular Research and Advanced Education at MedStar Heart & Vascular Institute. "We will be watching the results of this study closely as we strive to make minimally invasive procedures, such as TAVR, safe and effective for as many patients as possible."
The study is expected to enroll up to 200 patients in at least four centers across the U.S. In the trial, commercially available TAVR devices will be implanted in patients who would otherwise be candidates only for open-heart surgery. The study will compare this newly acquired TAVR data to historical controls from surgically-treated patients at each of the four sites in a patient-to-patient match.
About MedStar Heart & Vascular Institute:
MedStar Heart & Vascular Institute, founded at MedStar Washington Hospital Center in Washington, D.C., is a national leader in the research, diagnosis and treatment of cardiovascular disease, and has been consistently recognized by U.S. News & World Report and The Society of Thoracic Surgeons as one of the top cardiovascular programs in the nation. In January 2013, MedStar Heart formed a first-of-its-kind clinical and research alliance with world-renowned Cleveland Clinic Sydell and Arnold Miller Family Heart & Vascular Institute, the #1 heart program in the country. Together, MedStar Heart and Cleveland Clinic have forged a relationship of shared expertise that is transforming cardiovascular care, enhancing quality, improving safety and increasing access to advanced heart and vascular services. MedStar Heart & Vascular Institute comprises more than 140 cardiovascular physician specialists throughout the mid-Atlantic region, as well as the nationally recognized heart care of all nine MedStar Health acute care hospitals and MedStar National Rehabilitation Network.