Very simpleOptimum medical as control groupHospitalisation as...

Very simple
Optimum medical as control group
Hospitalisation as endpoint
Being easily met looking at last data from feasability trial
Can see why delay
FDA would very much like double blind , a least blind.
Just impossible when C-Pulse affects pulse in easily detectable manner (from memory oF patient article)
Can't do against VaAds not class 3 given safety profIle would probably never filled VAD arm.
Must have been back and foward exhaustively till all options but this exhausted.
Cheap trial?
Should put floor under price this is just an extension of current trial ( my opinion) which is easily meeting these endpoints.