The first patients in an early feasibility study of HLT’s transcatheter aortic valve implantation (TAVI) system have been implanted with the device. The implant procedures were completed at New York University’s Langone Medical Center by Mathew R Williams, who is the US principal investigator of HLT’s RADIANT clinical study.
The RADIANT trial, a press release reports, is a prospective, non-randomised, single-arm, multicentre study that will enrol up to 20 high-risk patients with severe aortic valve stenosis. The aim is to evaluate safety and performance outcomes of the Meridian TAVI device and the Pathfinder II delivery system. The primary endpoint is all-cause mortality at 30 days. Patient follow-up will occur at one, six and 12 months and annually to five years.
Williams says: “The HLT TAVI design enables us to fully assess valve function prior to releasing the valve in the heart, reposition it to achieve optimal performance prior to final release or retrieve it if necessary. As a result, our first procedure with the Meridian valve could be performed quickly and easily. In addition, the level of control that the system provides enabled us to perform the procedure under conscious sedation rather than general anaesthesia.”