Study of Leadless Pacemaker Implant Locations and Their Impact on Procedure Success and Safety

What this Trial Is About

Researchers are studying leadless pacemakers, which are implanted entirely inside the heart and avoid some problems seen with traditional pacemakers that have leads going through veins. This study focuses on where the leadless pacemaker attaches inside the right ventricle, especially looking at cases where the device is attached to the free wall of the right ventricle instead of the usual septal area. The goal is to learn if the extra effort to place the device on the septum is necessary by reviewing outcomes in patients with different implant locations. The study also explores if electrical signals recorded during implantation can predict the device position to help guide future procedures. Participants include patients who have already received or will receive a leadless pacemaker starting from January 2015. After implantation, patients will undergo a special non-contrast, ECG-gated CT scan of the heart timed at the end of the hearts relaxation phase to create 3D images that show the exact pacemaker attachment site. This will help determine where the device is located inside the right ventricle. Data from medical records, including demographics, medical history, lab tests, pacemaker electrical data, and medication use before and after implantation, will be collected for analysis. Participants will be invited for the heart CT scan after implantation, with the scan used to confirm the pacemakers location. Researchers will review the implant location and electrical data to study correlations. The main outcome measured is the implant location from enrollment to the CT scan within one year. Secondary outcomes include predicting implant location from electrical parameters. The study will monitor participants up to one year from enrollment to collect these data. Safety and complications related to implant location will be assessed through this follow-up.

Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication