2 results
Approved WMOCompleted
To evaluate the safety and performance of the Lotus Valve system for transcathether aortic valve replacment (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.
Approved WMOCompleted
The primary objective is to study whether the (early prototype) sensors are able to reliably measure the vital signs they are designed to record. The secondary objective is to determine the feasibility and user acceptance of the (early prototype)…