4 results
To determine the safety, feasibility and efficacy of targeted left ventricular lead placement with CRT procedures, using the CARTBox software.
CORE PERIODPrimary:* Evaluate the safety and tolerability of up to 24 weeks of AG-348 administration in patients with pyruvate kinase deficiency (PK deficiency).Secondary:* Evaluate the pharmacokinetics (PK) of AG-348 and the metabolite AGI-8702.*…
To establish the efficacy of targeted LV lead delivery in a sufficiently powered randomized, multicentre study. Efficacy is determined based on the distance of the LV-lead to the targeted cardiac segment, as determined pre-implantation by CARTBox.
Primary Endpoint: Feasibility of including patients in the study, randomization and delivery of the intervention. To assess the primary endpoint, we will examine the probability that: (1) a screened patient is eligible; (2) an eligible patient…