Chronic clinical performance of a novel subxiphoidal pacemaker system: Early feasibility study design

Background: Extravascular and leadless pacemakers are a new class of cardiac devices that may reduce the rate of complications common to traditional cardiac pacemakers with intracardiac leads. These devices also have the potential of expanding access to cardiac pacing therapy by simplifying the complexity and cost of implantation. The objective of this study is to evaluate the implantation, chronic safety, and performance of a novel subxiphoidal pacemaker. Methods: This study is an open-label, non-randomized, early feasibility study. Ten patients indicated for implantation of a single-chamber ventricular pacemaker will be enrolled and implanted with the investigational device. The pacemaker will be inserted underneath the ribcage and clipped to the xiphoid process, with stimulation electrodes positioned on the cardiac pericardium. Patients will be programmed to chronic pacing; pacing capture threshold, sensing amplitude, and lead impedance will be measured at implant and regularly scheduled follow-up visits. 24-h Holter ECG and cardiac troponin will also be periodically measured. Adverse events will be recorded throughout the study period. Conclusion: This study is designed to assess the feasibility, safety, and chronic performance of a novel extravascular pacemaker, and will provide valuable data on whether this device has the potential to be a viable alternative to conventional pacemakers.