Libbus Imad, Tholakanahalli Venkatakrishna, Roukoz Henri, Verma Varun, Isac Divya, Manicka Yatheendhar
Research & Development, Calyan Technologies, Saint Paul, Minnesota, USA.
School of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Pacing Clin Electrophysiol. 2024 Sep;47(9):1168-1170. doi: 10.1111/pace.15045. Epub 2024 Jul 16.
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.
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.
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.
血管外无导线起搏器是一类新型心脏设备，可能会降低传统有心内导线心脏起搏器常见的并发症发生率。这些设备还有望通过简化植入的复杂性和成本来扩大心脏起搏治疗的可及性。本研究的目的是评估一种新型剑突下起搏器的植入、长期安全性和性能。
本研究是一项开放标签、非随机的早期可行性研究。将招募10名有单腔心室起搏器植入指征的患者，并为其植入研究设备。起搏器将插入胸腔下方并夹在剑突上，刺激电极置于心脏心包上。患者将被程控为长期起搏；在植入时以及定期随访时测量起搏夺获阈值、感知幅度和导线阻抗。还将定期测量24小时动态心电图和心肌肌钙蛋白。在整个研究期间记录不良事件。
本研究旨在评估一种新型血管外起搏器的可行性、安全性和长期性能，并将提供关于该设备是否有可能成为传统起搏器可行替代方案的有价值数据。
