{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T00:40:10Z","timestamp":1760834410281,"version":"build-2065373602"},"reference-count":16,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2021,5,26]],"date-time":"2021-05-26T00:00:00Z","timestamp":1621987200000},"content-version":"unspecified","delay-in-days":25,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004374","name":"Medtronic","doi-asserted-by":"publisher","award":["ERP-2019-12060"],"award-info":[{"award-number":["ERP-2019-12060"]}],"id":[{"id":"10.13039\/100004374","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Hamamatsu University School of Medicine Grant-in-Aid","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,5,10]]},"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>jRCTs042200014; Pre-results.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-046782","type":"journal-article","created":{"date-parts":[[2021,5,26]],"date-time":"2021-05-26T14:38:10Z","timestamp":1622039890000},"page":"e046782","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["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"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9630-951X","authenticated-orcid":false,"given":"Yoshihisa","family":"Naruse","sequence":"first","affiliation":[{"name":"Division of Cardiology, Internal Medicine III, Hamamatsu University School of Medicine, Hamamatsu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keisuke","family":"Miyajima","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Seirei Mikatahara Hospital, Hamamatsu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryo","family":"Sugiura","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Seirei Hamamatsu Hospital, Hamamatsu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiro","family":"Muto","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Hamamatsu Medical Center, Hamamatsu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michio","family":"Ogano","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Shizuoka Medical Center, Sunto-gun, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nobutake","family":"Kurebayashi","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Chutoen General Medical Center, Kakegawa, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomoyuki","family":"Shiozawa","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Juntendo Shizuoka Hospital, Izunokuni, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yumi","family":"Kiyama","sequence":"additional","affiliation":[{"name":"Centre for Clinical Research, Hamamatsu University School of Medicine Hospital, Hamamatsu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eiko","family":"Nagata","sequence":"additional","affiliation":[{"name":"Centre for Clinical Research, Hamamatsu University School of Medicine Hospital, Hamamatsu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keiichi","family":"Odagiri","sequence":"additional","affiliation":[{"name":"Centre for Clinical Research, Hamamatsu University School of Medicine Hospital, Hamamatsu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuichiro","family":"Maekawa","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Internal Medicine III, Hamamatsu University School of Medicine, Hamamatsu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,5,26]]},"reference":[{"key":"2025101815060865000_11.5.e046782.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2020.05.017"},{"key":"2025101815060865000_11.5.e046782.2","doi-asserted-by":"publisher","DOI":"10.1253\/circj.CJ-10-1138"},{"key":"2025101815060865000_11.5.e046782.3","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1007\/s10840-019-00602-2","article-title":"Incidence and predictors of pacemaker-induced cardiomyopathy with comparison between apical and non-apical right ventricular pacing sites","volume":"56","author":"Bansal","year":"2019","journal-title":"J Interv Card Electrophysiol"},{"key":"2025101815060865000_11.5.e046782.4","doi-asserted-by":"crossref","first-page":"214","DOI":"10.1016\/j.ijcard.2016.06.250","article-title":"Implications of right ventricular septal pacing for medium-term prognosis: Propensity-matched analysis","volume":"220","author":"Mizukami","year":"2016","journal-title":"Int J Cardiol"},{"key":"2025101815060865000_11.5.e046782.5","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehu304"},{"key":"2025101815060865000_11.5.e046782.6","doi-asserted-by":"publisher","DOI":"10.1136\/openhrt-2018-000962"},{"key":"2025101815060865000_11.5.e046782.7","doi-asserted-by":"crossref","first-page":"921","DOI":"10.1016\/j.hrthm.2019.01.008","article-title":"Prognostic impact of lead tip position confirmed via computed tomography in patients with right ventricular septal pacing","volume":"16","author":"Hattori","year":"2019","journal-title":"Heart Rhythm"},{"key":"2025101815060865000_11.5.e046782.8","doi-asserted-by":"crossref","first-page":"174","DOI":"10.1016\/j.ihj.2015.10.382","article-title":"Inadequacy of fluoroscopy and electrocardiogram in predicting septal position in RVOT pacing - Validation with cardiac computed tomography","volume":"68","author":"Sharma","year":"2016","journal-title":"Indian Heart J"},{"key":"2025101815060865000_11.5.e046782.9","doi-asserted-by":"publisher","DOI":"10.1111\/pace.12301"},{"key":"2025101815060865000_11.5.e046782.10","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.113.000232"},{"key":"2025101815060865000_11.5.e046782.11","article-title":"Localization of right ventricular non-apical lead position: comparison of three-dimensional echocardiography, computed tomography, and fluoroscopic imaging","volume":"49","author":"Chen","year":"2021","journal-title":"J Int Med Res"},{"key":"2025101815060865000_11.5.e046782.12","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.117.006107"},{"key":"2025101815060865000_11.5.e046782.13","doi-asserted-by":"crossref","first-page":"1154","DOI":"10.1093\/europace\/eux165","article-title":"The usefulness of right ventriculography to aid anchoring a pacing lead to the right ventricular septum","volume":"20","author":"Shimeno","year":"2018","journal-title":"Europace"},{"key":"2025101815060865000_11.5.e046782.14","doi-asserted-by":"crossref","DOI":"10.1007\/s00380-021-01780-8","article-title":"The usefulness of a delivery catheter system for right ventricular \u201ctrue\u201d septal pacing","author":"Miyajima","year":"2021","journal-title":"Heart Vessels"},{"key":"2025101815060865000_11.5.e046782.15","first-page":"e382","article-title":"ACC\/AHA\/HRS guideline on the evaluation and management of patients with bradycardia and cardiac conduction delay: a report of the American College of Cardiology\/American heart association Task force on clinical practice guidelines and the heart rhythm Society","volume":"2019","author":"Kusumoto","year":"2018","journal-title":"Circulation"},{"key":"2025101815060865000_11.5.e046782.16","article-title":"Comparison between his-bundle pacing and left bundle branch pacing in patients with atrioventricular block","author":"Hu","year":"2020","journal-title":"J Interv Card Electrophysiol"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2020-046782","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T22:06:14Z","timestamp":1760825174000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2020-046782"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5]]},"references-count":16,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2021,5,26]]},"published-print":{"date-parts":[[2021,5]]}},"alternative-id":["10.1136\/bmjopen-2020-046782"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2020-046782","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2021,5]]}}}