2 results
Approved WMOCompleted
To make an efficacy evaluation of Gadolineum Ethoxybenzyl (Gd-EOB) DTPA-enhanced MR-imaging (Gadoxetic acid, Primovist, Bayer Schering Pharma, Berlin) and Respiratory Triggered Diffusion Weighted Imaging (DWI) for the detection and characterization…
Approved WMOCompleted
Primary Study Objectives:Safety objective: assessment of procedure related mortality up to 30 days post-procedure.Performance objective: demonstration of the ability of Valvosoft to modify the structure of the calcified valve leaflets to improve…