Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter (EASY II Trial)

Cardiac pacing is crucial for patients with hemodynamically unstable bradyarrhythmias. For most indications, transvenous pacemakers are used to pace the right ventricle, causing atrioventricular dyssynchrony, which may lead to significant hemodynamic compromise. This study introduces the sync-atrio-ventricular (AV) II temporary cardiac pacing catheter, designed to provide dual-chamber AV sequential pacing with a single catheter, preserving AV synchrony.

To evaluate the efficacy and safety of the sync-AV II temporary cardiac pacing catheter for temporary pacing support in patients undergoing elective surgical or interventional procedures.

This prospective, single-center, open-label study involved 30 subjects requiring temporary cardiac pacing. The swift sync-AV II catheter, capable of atrioventricular sequential pacing through a single catheter, was evaluated for ease of use, pacing thresholds, and safety outcomes.

All 30 subjects were successfully implanted with the swift sync-AV II temporary pacemaker. The primary efficacy endpoint-ventricular pacing threshold at 24 h post-implantation-met the pre-specified performance goal. The device demonstrated high technical success, with no reported serious procedure-related complications. Atrial and ventricular pacing thresholds remained within acceptable ranges throughout the study period.

The sync-AV II temporary cardiac pacing catheter is effective and safe for providing temporary AV sequential pacing in patients undergoing elective procedures. It represents a significant advancement in temporary pacing technology, with the potential to improve hemodynamic outcomes and reduce complications associated with traditional single-chamber right ventricular pacing methods.