The FDA has given investigational device exemption (IDE) approval to MedStar Heart and Vascular Institute at MedStar Washington Hospital Center (Washington, DC, USA) to start a new study of transcatheter aortic valve implantation (TAVI) in patients with aortic stenosis who are at low risk of surgical mortality.
A press release reports that the study will be the first in the USA to investigate whether benefits with TAVI observed in inoperable and high-risk patients are also found in a lower-risk population. This investigator-initiated study will also examine the phenomenon of leaflet thrombosis detected with advanced imaging and will enrol a total of 200 patients in up to four centres in the USA. The MedStar Washington Hospital Center will be the first site in the US to enrol patients into this IDE study, which includes the implantation of commercially available TAVI devices in patients who before now were candidates only for surgical aortic valve replacement. The study will compare these newly acquired TAVI data to historical controls from surgical patients at each of the four sites in a patient-to-patient match. It is anticipated that patients will be able to enrol into the study in January 2016.
Ron Waksman (lead investigator of the study and director of Cardiovascular Research and Advanced Education at the MedStar Heart & Vascular Institute), says: “We appreciate the FDA’s trust in our ability to conduct this important investigation of TAVI and its safety and efficacy in the low-risk population.”
Paul Corso (co-principal investigator and chair of Cardiac Surgery at MedStar Heart & Vascular Institute) comments: “Our heart team is excited to have the opportunity to examine the safety and the potential benefit of TAVI 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.”