3 results
Approved WMOPending
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
Approved WMOCompleted
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
Approved WMOCompleted
The overall aim of this study is to investigate whether the HEART score, which has proven to be safe in previous studies, can be implemented on large scale.