2 results
Approved WMOPending
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by a Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery
Approved WMOCompleted
Primary objective:To characterize safety and tolerability of each treatment arm tested and identify recommended doses (RD) and regimens for future studies, by assessing the incidence and severity of AEs and SAEs; including changes in laboratory…