8 results
Primary Objective To evaluate long term safety and tolerability of LAI (590 mg) administered once daily (QD) for up to 12 months in subjects who were refractory to standard multi-drug treatment and failed to convert in Study INS-212. Secondary…
Demonstrate the sensitivity of the diagnostic feature "Physiological Diagnostic" (PhD) to detect clinically relevant HF-related events and to demonstrate a reasonable number of false positive indications.
The overall aim of the DALI study is to identify the best available measures to prevent GDM in an ongoing pregnancy, to provide a cost-benefit calculation of GDM prevention for health care systems, and to establish a pan-European cohort of mother-…
In the present clinical investigation, we will perform an analysis of baseline risk factors to identify predictors for appropriate ICD intervention in patients with ischemic cardiomyopathy receiving an ICD for primary prevention (MADIT II population…
The overall aim of the DALI study is to identify the best available measures to prevent GDM in an ongoing pregnancy, to provide a cost-benefit calculation of GDM prevention for health care systems, and to establish a pan-European cohort of mother-…
(1) to determine the feasibility to sense and pace the myocardium with an- ICD lead placed in an alternative position (2) to determine the best position for pacing and sensing in the alternative position(3) to determine the safety and feasibility to…
Primary-Assess the efficacy of apitegromab compared with placebo using the HFMSE in patients 2 through 12 years oldKey secondary-Assess the efficacy of apitegromab compared with placebo based on the number of patients with clinical improvement in…
-Evaluate the long-term safety and tolerability of apitegromab in patients with Type 2 and Type 3 SMA-Evaluate the long-term efficacy of apitegromab by assessing changes in motor function outcome measures at prespecified time points-Further evaluate…