Evidence map›Paper›PMID 34039576›Full record

ArticleBMJ open2021

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.

Yoshihisa Naruse, Keisuke Miyajima, Ryo Sugiura, Masahiro Muto, Michio Ogano, Nobutake Kurebayashi, Tomoyuki Shiozawa, Yumi Kiyama, Eiko Nagata, Keiichi Odagiri and 2 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Usefulness of delivery catheter on accurate right ventricular septal pacing: Mt FUJI trial.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023
    Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 1 country.

Yoshihisa NaruseDivision of Cardiology, Internal Medicine III, Hamamatsu University School of Medicine, Hamamatsu, Japan ynaruse@hama-med.ac.jp.ORCID 0000-0001-9630-951X
Keisuke MiyajimaDepartment of Cardiology, Seirei Mikatahara Hospital, Hamamatsu, Japan.
Ryo SugiuraDepartment of Cardiology, Seirei Hamamatsu Hospital, Hamamatsu, Japan.
Masahiro MutoDepartment of Cardiology, Hamamatsu Medical Center, Hamamatsu, Japan.
Michio OganoDepartment of Cardiovascular Medicine, Shizuoka Medical Center, Sunto-gun, Japan.
Nobutake KurebayashiDepartment of Cardiology, Chutoen General Medical Center, Kakegawa, Japan.
Tomoyuki ShiozawaDepartment of Cardiology, Juntendo Shizuoka Hospital, Izunokuni, Japan.
Yumi KiyamaCentre for Clinical Research, Hamamatsu University School of Medicine Hospital, Hamamatsu, Japan.
Eiko NagataCentre for Clinical Research, Hamamatsu University School of Medicine Hospital, Hamamatsu, Japan.
Keiichi OdagiriCentre for Clinical Research, Hamamatsu University School of Medicine Hospital, Hamamatsu, Japan.
Yuichiro MaekawaDivision of Cardiology, Internal Medicine III, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Mt. FUJI trial investigators
Hamamatsu University School of Medicine · JPHamamatsu Medical Center · JPJuntendo University Shizuoka Hospital · JPSeirei Hamamatsu General Hospital · JPSeirei Social Welfare Community · JPShizuoka Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPacing-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.

Indexed as

Ventricular SeptumCathetersHeart VentriclesHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicSingle-Blind MethodTomography, X-Ray Computedadult cardiologyclinical trialspacing & electrophysiology

Identifiers

PMID34039576
PMCPMC8160162
OpenAlexW3165600678

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.