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.