3 results
Primary Objective - To determine if afamelanotide can reduce the severity of PLE related pruritis.Secondary Objectives- To determine if afamelanotide can reduce the frequency of PLE episodes;- To determine if afamelanotide can reduce the duration of…
Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…
We hypothesize that a noninvasive ECGI mapping-based system, like the Amycard 01C system, can provide information valuable for both selecting patients for CRT therapy, planning the CRT procedure, guiding the actual CRT lead placement during…