BMJ Open (Jun 2021)
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
- Satoru Suwa,
- Jun Tanabe,
- Ryo Sugiura,
- Manabu Ogita,
- Yoshihisa Naruse,
- Keisuke Miyajima,
- Masahiro Muto,
- Michio Ogano,
- Nobutake Kurebayashi,
- Tomoyuki Shiozawa,
- Yumi Kiyama,
- Eiko Nagata,
- Keiichi Odagiri,
- Yutaro Kaneko,
- Tomoaki Sakakibara,
- Taro Narumi,
- Satoshi Mogi,
- Kenichiro Suwa,
- Hayato Ohtani,
- Masao Saotome,
- Tuyoshi Urushida,
- Akira Mizukami,
- Hideyuki Hasebe,
- Keisuke Iguchi,
- Akiko Atsumi,
- Naoya Inoue,
- Tomoya Iwawaki,
- Tomotaka Suzuki,
- Takashi Ogane,
- Naoki Tsurumi,
- Yumiko Joko,
- Shuji Morikawa,
- Hideki Wada,
- Shintaro Takano,
- Jun Shitara,
- Shoichiro Yatsu,
- Taketo Sonoda,
- Kentaro Yasuda,
- Ryota Nishio,
- Daigo Takahashi,
- Go Ishikawa,
- Soushi Moriya,
- Kei Kimura,
- Kohei Sawasaki,
- Natsuko Hosoya,
- Yasushi Wakabayashi,
- Yoshitaka Kawaguchi,
- Tomoyuki Watanabe,
- Yasuyo Takashima,
- Ayako Okazaki,
- Kazuki Ito,
- Ryuta Henmi,
- Daichi Isomura,
- Hideki Saito,
- Yoshinobu Kato
Affiliations
- Satoru Suwa
- Department of Cardiovascular Medicine, Juntendo University Shizuoka Hospital, Izunokuni, Japan
- Jun Tanabe
- Department of Comprehensive Strokology, Fujita Health University, Toyoake, Aichi, Japan
- Ryo Sugiura
- 1 Department of Gastroenterology and Hepatology, Hokkaido University Faculty of Medicine and Graduate School of Medicine, Sapporo, Japan
- Manabu Ogita
- Departments of Cardiology, Juntendo University, School of Medicine, Tokyo, Japan
- Yoshihisa Naruse
- Division of Cardiology, Internal Medicine III, Hamamatsu University School of Medicine, Hamamatsu, Japan
- Keisuke Miyajima
- Department of Cardiology, Seirei Mikatahara Hospital, Hamamatsu, Japan
- Masahiro Muto
- Department of Cardiology, Hamamatsu Medical Center, Hamamatsu, Japan
- Michio Ogano
- Department of Cardiovascular Medicine, Shizuoka Medical Center, Sunto-gun, Japan
- Nobutake Kurebayashi
- Department of Cardiology, Chutoen General Medical Center, Kakegawa, Japan
- Tomoyuki Shiozawa
- Department of Cardiology, Juntendo Shizuoka Hospital, Izunokuni, Japan
- Yumi Kiyama
- Centre for Clinical Research, Hamamatsu University School of Medicine Hospital, Hamamatsu, Japan
- Eiko Nagata
- Centre for Clinical Research, Hamamatsu University School of Medicine Hospital, Hamamatsu, Japan
- Keiichi Odagiri
- Centre for Clinical Research, Hamamatsu University School of Medicine Hospital, Hamamatsu, Japan
- Yutaro Kaneko
- Tomoaki Sakakibara
- Taro Narumi
- Satoshi Mogi
- Kenichiro Suwa
- The Investigator Group, Hamamatsu Circulation Forum; (Hamamatsu Circulation Forum consists of Enshu Hospital, Hamamatsu University Hospital, Hamamatsu Red Cross Hospital, Kosai General Hospital and Seirei Mikatahara Hospital.)
- Hayato Ohtani
- The Investigator Group, Hamamatsu Circulation Forum; (Hamamatsu Circulation Forum consists of Enshu Hospital, Hamamatsu University Hospital, Hamamatsu Red Cross Hospital, Kosai General Hospital and Seirei Mikatahara Hospital.)
- Masao Saotome
- The Investigator Group, Hamamatsu Circulation Forum; (Hamamatsu Circulation Forum consists of Enshu Hospital, Hamamatsu University Hospital, Hamamatsu Red Cross Hospital, Kosai General Hospital and Seirei Mikatahara Hospital.)
- Tuyoshi Urushida
- Akira Mizukami
- Hideyuki Hasebe
- Keisuke Iguchi
- Akiko Atsumi
- Naoya Inoue
- Tomoya Iwawaki
- Tomotaka Suzuki
- Takashi Ogane
- Naoki Tsurumi
- Yumiko Joko
- Shuji Morikawa
- Hideki Wada
- Shintaro Takano
- Jun Shitara
- Shoichiro Yatsu
- Taketo Sonoda
- Kentaro Yasuda
- Ryota Nishio
- Daigo Takahashi
- Go Ishikawa
- Soushi Moriya
- Kei Kimura
- Kohei Sawasaki
- Natsuko Hosoya
- Yasushi Wakabayashi
- The Investigator Group, Hamamatsu Circulation Forum; (Hamamatsu Circulation Forum consists of Enshu Hospital, Hamamatsu University Hospital, Hamamatsu Red Cross Hospital, Kosai General Hospital and Seirei Mikatahara Hospital.)
- Yoshitaka Kawaguchi
- Tomoyuki Watanabe
- Yasuyo Takashima
- Ayako Okazaki
- Kazuki Ito
- Ryuta Henmi
- Daichi Isomura
- Hideki Saito
- Yoshinobu Kato
- DOI
- https://doi.org/10.1136/bmjopen-2020-046782
- Journal volume & issue
-
Vol. 11,
no. 5
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.
