Study Design
This first-in-human, prospective, single-center, and single-arm study
assessed the feasibility and safety of a new temporary AV sequential
system in patients undergoing cardiac catheterization. Swift Sync Inc
sponsored the study. This study was based on positive outcomes from a
pilot animal study. All patients were enrolled, and studies were
completed in a single center in Asuncion, Paraguay, in May of 2018.
Institutional Review Board approval was granted, and every patient
obtained informed consent.