2 results
Approved WMOWill not start
Primary: To evaluate the safety of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery.Secondary: To evaluate adverse events and study device performance.
Approved WMOPending
The primary objective of this study is to determine the safety and feasibility of turbine-based insufflation, measured in terms of occurrence of adverse device effects and serious adverse device effects. The secondary objectives are to determine theā¦