MedStar Heart & Vascular Institute to Initiate IDE Trial of TAVR in Low-Risk Symptomatic Patients

November 23, 2015—MedStar Heart & Vascular Institute at MedStar Washington Hospital Center in Washington, DC, announced that the US Food and Drug Administration (FDA) granted the institution the first investigational device exemption (IDE) to evaluate the safety and effectiveness of transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis who are at low risk for surgical mortality.

MedStar noted that currently, the indication for TAVR is limited to patients with high surgical risk or those who are inoperable, and TAVR is currently under ongoing evaluation in patients with intermediate surgical risk.

According to MedStar, the IDE study will be the first in the United States to investigate whether the promising results of TAVR in these patients are comparable in a lower-risk population. This investigator-initiated study will also examine the phenomenon of leaflet thrombosis detected with advanced imaging and will enroll a total of 200 patients in up to four centers in the United States.

MedStar Washington Hospital Center will be the first site in the United States to enroll patients into this IDE trial. In the trial, commercially available TAVR devices will be implanted in patients who would otherwise be candidates only for surgical aortic valve replacement. The study will compare this newly acquired TAVR data to historical controls from surgical replacement patients at each of the four sites in a patient-to-patient match. It is anticipated that patients will be able to enroll into the study in January 2016.

The study’s lead investigator is Ron Waksman, MD, who is Director of Cardiovascular Research and Advanced Education at MedStar Heart & Vascular Institute. In the announcement, Dr. Waksman 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. This is a natural evolution in the field.”

Coprincipal Investigator Paul Corso, MD, who is Chair of Cardiac Surgery at MedStar Heart & Vascular Institute, added, “Our heart team is excited to have the opportunity to examine the safety and the potential benefit of TAVR for patients in the low-risk category. We will be watching the results of this study closely as we strive to make minimally invasive procedures safe and effective for as many patients as possible.”