Study of Slew Rate to Predict Best Lead Placement in Pacemakers and Implantable Cardioverter-Defibrillators Observational Multicenter Study Monitoring Electrical Parameters Over 12 Months

What this Trial Is About

Researchers are investigating electrical measurements taken during the implantation of transvenous pacemakers and implantable cardioverter-defibrillators ICDs to find the best predictors of long-term lead performance. The study focuses on whether the slew rate and other electrical parameters measured at implantation correlate with device function at 12 months. The goal is to improve the selection of optimal pacing sites to prevent device problems over time. This is a prospective observational study involving patients receiving active fixation leads for pacemakers or ICDs. Electrical parameters like slew rate, current of injury, sensing, impedance, and capture threshold will be measured before and after lead fixation using a consistent pacing system analyzer. Follow-up visits occur at 1 and 12 months after implantation, with assessments done in-person or via remote monitoring according to standard care. Participants will have their devices electrical parameters checked regularly, including sensing, impedance, and capture threshold, from implantation through the 12-month follow-up. Lead dislodgement and any significant changes in electrical measurements will also be monitored. The main outcome is the slew rate value measured at implantation prior to helix deployment, with secondary outcomes including current of injury and ongoing electrical performance over time.

Slew Rate As a Predictor for Optimal Lead Fixation