MedStar Announces First-of-Its-Kind Study Aimed at Evaluating Use of Less Invasive Procedure in Low Risk Patients with Diseased Heart Valves

MedStar Heart & Vascular Institute at MedStar Washington Hospital Center announced that it would 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 FDA granted an Investigational Device Exemption, which allows the company to use the investigational device in a research setting, and to enroll these patients into the study, which is starting this month.
According to the company’s press release:

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.

Ron Waksman, MD, lead investigator of the study and director of Cardiovascular Research and Advanced Education at MedStar Heart & Vascular Institute commented:

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. 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.

Click here to view the full press release.