6 results
Primary objectives:- to assess the safety and tolerability of bolus doses of ABP-700 in the presence of pre-medications commonly used in the monitored anesthesia care (MAC) setting.- to optimize bolus dosing of ABP-700 in combination with pre-…
primary objective: To evaluate the long-term safety and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis (CF), homozygous or heterozygous for the F508del-cystic fibrosis transmembrane conductance regulator (…
The purpose of this study is to evaluate the implant procedure and feasibility of the Model 20066 LV lead. The proposed Model 20066 study will provide data to assess the safety and feasibility of the Model 20066 fixation concept. It is also expected…
Primary ObjectiveTo evaluate the efficacy of lumacaftor in combination with ivacaftor throughat Week 24 in subjects with cystic fibrosis (CF) who are homozygous for the F508del CFTR mutation on the CF transmembrane conductance regulator (CFTR)…
Primary objectives:- To assess the safety and tolerability of intravenous (IV) infusion doses and infusion dosing methodologies of ABP-700 alone or in the presence of pre-medications commonly used in the monitored anesthesia care (MAC) setting.- To…
The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quad MRI SureScan LV lead (Model 4798) in patients indicated for a de novo LV lead implant. This will be assessed through primary safety and primary…