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

Kenichiro Yamagata, Kohei Ishibashi, Kenzaburo Nakajima, Naoya Kataoka, Tsukasa Kamakura, Mitsuru Wada, Yuko Inoue, Koji Miyamoto, Satoshi Nagase, Takashi Noda, Takeshi Aiba, Satoshi Yasuda, Kengo Kusano

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)524-527
Number of pages4
Journaljournal of arrhythmia
Volume35
Issue number3
DOIs
Publication statusPublished - 2019 Jun 1
Externally publishedYes

Keywords

  • catheter delivery system
  • pacemaker implantation
  • randomized trial
  • stylet delivery system
  • trainee

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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