Comparing the catheter delivery system and the stylet delivery system for ventricular lead placement in pacemaker implantation—The CATS delivery system randomized controlled trial

BACKGROUND: Right ventricular lead placement is one of the fundamental procedures during pacemaker implantation through the subclavian vein. Currently, there are two techniques to deliver the lead to the right ventricle: the catheter and stylet delivery systems. Surgeons, especially trainees in the early stage of training, are known to face difficulty while delivering the lead to the right ventricle. The objective of this study is to investigate and compare the two techniques of lead delivery by trainees in patients who are scheduled to undergo pacemaker implantation. METHODS: This is a prospective, single-center, randomized controlled clinical trial. One-hundred patients who were scheduled to undergo pacemaker implantation with a right ventricular lead will be randomized such that the pacemaker can be implanted via either the catheter delivery system or the stylet delivery system at a 1:1 ratio. The primary endpoint is the total number of attempts needed to place the lead in the ideal position. Secondary endpoints are the efficacy and safety of the implantation procedure. All implantation procedures will be performed by trainees under the supervision of expert cardiologists. RESULTS: The results of this study are currently under investigation. CONCLUSION: This will be the first clinical trial to compare the efficacy and safety of the catheter delivery system and the stylet delivery system during the implantation of the ventricular lead in pacemaker implantation. Our findings are expected to improve the lead implantation procedure by providing information about which delivery system to choose in which situation.