2 results
Approved WMOCompleted
Primary Objectives* To evaluate the efficacy of SCY-078 as determined by a Data Monitoring Committee(DMC) by assessing global success (composite assessment of clinical and mycologicalsuccess) at EoT* To evaluate the safety of SCY-078
Approved WMOCompleted
Establish the technical feasibility and safety of implantation of the investigational device, adjustment of the investigational device post-implantation and the ability of the investigational device to reduce mitral valve regurgitation.