Comparison of delivery catheter-based and stylet-based right ventricular lead placement at the right ventricular septum under fluoroscopic guidance judged by cardiac CT (Mt. FUJI): a study protocol for the Mt. FUJI randomised controlled trial. Issue 5 (26th May 2021)

• Record Type: Journal Article
• Authors: Naruse, Yoshihisa; Miyajima, Keisuke; Sugiura, Ryo; Muto, Masahiro; Ogano, Michio; Kurebayashi, Nobutake; Shiozawa, Tomoyuki; Kiyama, Yumi; Nagata, Eiko; Odagiri, Keiichi; Maekawa, Yuichiro
• Other Names: author non-byline.; Kaneko Yutaro author non-byline.; Sakakibara Tomoaki author non-byline.; Narumi Taro author non-byline.; Sano Makoto author non-byline.; Mogi Satoshi author non-byline.; Suwa Kenichiro author non-byline.; Ohtani Hayato author non-byline.; Saotome Masao author non-byline.; Urushida Tuyoshi author non-byline.; Mizukami Akira author non-byline.; Hasebe Hideyuki author non-byline.; Iguchi Keisuke author non-byline.; Atsumi Akiko author non-byline.; Inoue Naoya author non-byline.; Iwawaki Tomoya author non-byline.; Suzuki Tomotaka author non-byline.; Ogane Takashi author non-byline.; Tsurumi Naoki author non-byline.; Joko Yumiko author non-byline.; Morikawa Shuji author non-byline.; Suwa Satoru author non-byline.; Ogita Manabu author non-byline.; Wada Hideki author non-byline.; Takano Shintaro author non-byline.; Shitara Jun author non-byline.; Yatsu Shoichiro author non-byline.; Sonoda Taketo author non-byline.; Yasuda Kentaro author non-byline.; Nishio Ryota author non-byline.; Takahashi Daigo author non-byline.; Ishikawa Go author non-byline.; Moriya Soushi author non-byline.; Kimura Kei author non-byline.; Tanabe Jun author non-byline.; Sawasaki Kohei author non-byline.; Takayama Yohei author non-byline.; Hosoya Natsuko author non-byline.; Wakabayashi Yasushi author non-byline.; Kawaguchi Yoshitaka author non-byline.; Watanabe Tomoyuki author non-byline.; Takashima Yasuyo author non-byline.; Okazaki Ayako author non-byline.; Ito Kazuki author non-byline.; Henmi Ryuta author non-byline.; Isomura Daichi author non-byline.; Saito Hideki author non-byline.; Kato Yoshinobu author non-byline.;
• Is Part Of: BMJ open. Volume 11:Issue 5(2021)
• Publication Date: 2021-05-26
• Subjects: pacing & electrophysiology -- adult cardiology -- clinical trials; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-046782
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Pacing-induced cardiomyopathy occasionally occurs in patients undergoing pacemaker implantation. Although compared with right ventricular (RV) apical pacing, RV septal pacing can attenuate left ventricular dyssynchrony; the success rate of lead placement on the RV septum using the stylet system is low. Additionally, no randomised controlled trial has addressed the issue regarding the accuracy of RV lead placement on the RV septum using the stylet and delivery catheter systems. This study hypothesises that a newly available delivery catheter system can improve the accuracy of RV lead placement on the RV septum. Methods and analysis: In a multicentre, prospective, randomised, single-blind, controlled trial, 70 patients with pacemaker indication owing to atrioventricular block will be randomised to either the delivery catheter or stylet group before the pacemaker implantation procedure. The position of the RV lead tip will be assessed using ECG-gated cardiac CT in all patients within 4 weeks after pacemaker implantation. Lead tip positions are classified into three groups: (1) RV septum, (2) anterior/posterior edge of the RV septal wall and (3) RV free wall. The primary endpoint will be the success rate of RV lead tip placement on the RV septum, which will be evaluated using cardiac CT. Ethics and dissemination: This study will be conducted according to the stipulations of the Helsinki Declaration and the institutional review board of Hamamatsu University School of Medicine. The results of the study will be disseminated at several research conferences and will be published in peer-reviewed journals. Trial registration number: jRCTs042200014; Pre-results.