Safety and Efficacy of a Novel Blunt-Tip Concealed-Needle Epicardial Access Device: First-in-Human Feasibility Study

JACC Clin Electrophysiol. 2022 Jul;8(7):908-912. doi: 10.1016/j.jacep.2022.04.016. Epub 2022 Apr 30.

Abstract

Epicardial access is becoming increasingly important for various cardiovascular interventions. Access to dry pericardial space can be challenging and is often associated with significant complications. A novel concealed-needle blunt-tip device is designed to capture the parietal pericardium layer and retract it into the distal end of the device, which houses a fixated concealed needle, in a bid to minimize the likelihood of lacerating the visceral layer of the pericardium. This prospective single-arm study evaluated the feasibility of use of this device in 11 human subjects with successful access attained in 91% (10 of 11) of cases without adverse events. (Pericardial Access With ViaOne Device; NCT05006157).

Keywords: blunt tip; cardiac perforation; concealed needle; epicardial access.

Publication types

  • Review

MeSH terms

  • Clinical Studies as Topic
  • Feasibility Studies
  • Humans
  • Pericardium* / surgery
  • Prospective Studies

Associated data

  • ClinicalTrials.gov/NCT05006157