4 results
Primary objectives:1) To evaluate the safety and tolerability of multiple doses GAL-021 in healthy volunteers.2) To evaluate the pharmacokinetic profile of multiple doses of GAL-021 in healthy volunteers.3) To evaluate the pharmacodynamic effects at…
The primary objective of this study is to evaluate the safety and performance of the Permaseal device for left ventricular transapical access and closure and to gain data that will lead to CE-Mark approval for the Permaseal device.
PrimaryPart 1: - To determine the respiratory response of low and high doses of GAL-021 in conjunction with a low dose of opioids and hypercapnia in healthy subjects. Part 2: - To determine the respiratory response of low and high doses of GAL-021…
Using state of the art CMR imaging techniques, we will characterize ablation lesions in the early phase after pulmonary vein isolation, and relate findings to (1) the ablation scar at 3 months follow up and (2) atrial fibrillation-free survival at 1…