Evaluation of a Portable Smart ECG System to Assist Left Bundle Branch Area Pacing LBBAP During Cardiac Device Implantation

What this Trial Is About

This research aims to evaluate the ability to monitor Left Bundle Branch Area Pacing LBBAP success criteria using a Smart ECG system during cardiac device implantation. The study focuses on supporting physicians by providing a portable, easy-to-use ECG display and automatic calculation of key ECG indicators such as Left Ventricular Activation Time LVAT and V6-V1 interval. This helps doctors concentrate on lead placement with immediate ECG measurements provided by the software. The Smart ECG system consists of a CE-marked Class IIa device, including an ECG monitor, 12-lead ECG cables, ECG viewer software HookUp Smart V2, and a commercial PC to display and analyze ECG data. The system is used alongside an Electrophysiology ECG monitoring system during pacemaker or cardiac resynchronization therapy CRT implantation involving the placement of a pacing lead in the interventricular septum. The study is pre-market and non-pivotal, focusing on device performance and safety based on non-clinical testing. Participants with an indication for LBBAP will undergo the procedure with the Smart ECG system used in addition to the standard EP system. Researchers will assess the capability to monitor LBB success criteria, accuracy of key ECG measurements, identification of LBB transitions, type of LBB capture, signal quality, investigator satisfaction, and safety during the procedure. The study includes baseline and procedure evaluations, with participants followed through the implant process to gather these outcomes.

Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution