2 results
Approved WMOCompleted
The primary objective of the study is to generate safety and performance data for the CardiAQ* Transcatheter Mitral Valve Implant System with the Transapical Delivery System to support a future marketing application for the treatment of moderate to…
Approved WMOCompleted
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…