Efficacy and safety of left bundle branch area pacing versus right ventricular apex pacing in patients with atrioventricular block: study protocol for a randomised controlled trial
Introduction Left bundle branch area pacing (LBBaP) is a relatively new approach for physiologic pacing. A limited number of retrospective clinical studies, featuring small sample sizes, have shown that compared with right ventricular apex pacing (RVAP), the QRS duration of postoperative ECG in LBBa...
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BMJ Publishing Group
2021-06-01
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| author | Junjun Chen Liting Cheng Junmeng Zhang Zefeng Wang Zhuo Liang Jieruo Chen Yongquan Wu Xiao Du Ruiqing Dong Fei Hang Xinlu Wang Ziyu Wang |
| author_facet | Junjun Chen Liting Cheng Junmeng Zhang Zefeng Wang Zhuo Liang Jieruo Chen Yongquan Wu Xiao Du Ruiqing Dong Fei Hang Xinlu Wang Ziyu Wang |
| author_sort | Junjun Chen |
| collection | DOAJ |
| description | Introduction Left bundle branch area pacing (LBBaP) is a relatively new approach for physiologic pacing. A limited number of retrospective clinical studies, featuring small sample sizes, have shown that compared with right ventricular apex pacing (RVAP), the QRS duration of postoperative ECG in LBBaP patients is narrower and the cardiac systolic function is improved. However, there have been no randomised controlled trials (RCTs) evaluating the efficacy and safety of LBBaP in patients with atrioventricular block (AVB). Therefore, the current study intends to address the paucity in RCT data evaluating LBBaP versus RVAP in AVB patients.Analysis and methods This study is a single-centre, randomised controlled superiority trial to be conducted at the Cardiac Centre of Beijing Anzhen Hospital. From January 2021 to December 2023, 210 consecutive AVB patients meeting the inclusion criteria and receiving pacemaker implantation will be enrolled. Participants will be randomly divided into an experimental group (LBBaP) and a control group (RVAP) at a 1:1 ratio. The primary outcome is left ventricular ejection fraction (LVEF), which will be assessed by echocardiography. The secondary outcomes in this study are synchrony of left ventricular systole, NT-proBNP, LVEDD, the 6-min walk distance, quality of life (SF-36 scale), all-cause mortality, cardiovascular death events, rehospitalisation rate and major complication rate.Ethics and dissemination This study was approved by the Medical Ethics Committee of Beijing Anzhen Hospital (No. 2020021X). The results of the trial will be presented at national and international conferences. We hypothesise that compared with RVAP, LBBaP will be superior for treating patients with AVB. This trial will provide evidence-based suggestion for the majority of electrophysiologists in pacing implantation.Trial registration ChiCTR2000034335. |
| format | Article |
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| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-06-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-d9a3580dc52c4152a6b442279ec620372024-11-19T11:35:13ZengBMJ Publishing GroupBMJ Open2044-60552021-06-0111610.1136/bmjopen-2020-043603Efficacy and safety of left bundle branch area pacing versus right ventricular apex pacing in patients with atrioventricular block: study protocol for a randomised controlled trialJunjun Chen0Liting Cheng1Junmeng Zhang2Zefeng Wang3Zhuo Liang4Jieruo Chen5Yongquan Wu6Xiao Du7Ruiqing Dong8Fei Hang9Xinlu Wang10Ziyu Wang11Department of Critical Care Medicine, West China Tianfu Hospital of Sichuan University, Chengdu, People`s Republic of ChinaBeijing An Zhen Hospital, Chaoyang-qu, ChinaDepartment of Cardiology, Beijing An Zhen Hospital, Chaoyang-qu, Beijing, ChinaBeijing An Zhen Hospital, Chaoyang-qu, ChinaBeijing An Zhen Hospital, Chaoyang-qu, ChinaBeijing An Zhen Hospital, Chaoyang-qu, ChinaDepartment of Cardiology, Beijing An Zhen Hospital, Chaoyang-qu, ChinaDepartment of Cardiology, Beijing An Zhen Hospital, Chaoyang-qu, Beijing, ChinaDepartment of Cardiology, Beijing An Zhen Hospital, Chaoyang-qu, Beijing, ChinaDepartment of Cardiology, Beijing An Zhen Hospital, Chaoyang-qu, Beijing, ChinaDepartment of Cardiology, Beijing An Zhen Hospital, Chaoyang-qu, Beijing, ChinaDepartment of Cardiology, Beijing An Zhen Hospital, Chaoyang-qu, Beijing, ChinaIntroduction Left bundle branch area pacing (LBBaP) is a relatively new approach for physiologic pacing. A limited number of retrospective clinical studies, featuring small sample sizes, have shown that compared with right ventricular apex pacing (RVAP), the QRS duration of postoperative ECG in LBBaP patients is narrower and the cardiac systolic function is improved. However, there have been no randomised controlled trials (RCTs) evaluating the efficacy and safety of LBBaP in patients with atrioventricular block (AVB). Therefore, the current study intends to address the paucity in RCT data evaluating LBBaP versus RVAP in AVB patients.Analysis and methods This study is a single-centre, randomised controlled superiority trial to be conducted at the Cardiac Centre of Beijing Anzhen Hospital. From January 2021 to December 2023, 210 consecutive AVB patients meeting the inclusion criteria and receiving pacemaker implantation will be enrolled. Participants will be randomly divided into an experimental group (LBBaP) and a control group (RVAP) at a 1:1 ratio. The primary outcome is left ventricular ejection fraction (LVEF), which will be assessed by echocardiography. The secondary outcomes in this study are synchrony of left ventricular systole, NT-proBNP, LVEDD, the 6-min walk distance, quality of life (SF-36 scale), all-cause mortality, cardiovascular death events, rehospitalisation rate and major complication rate.Ethics and dissemination This study was approved by the Medical Ethics Committee of Beijing Anzhen Hospital (No. 2020021X). The results of the trial will be presented at national and international conferences. We hypothesise that compared with RVAP, LBBaP will be superior for treating patients with AVB. This trial will provide evidence-based suggestion for the majority of electrophysiologists in pacing implantation.Trial registration ChiCTR2000034335.https://bmjopen.bmj.com/content/11/6/e043603.full |
| spellingShingle | Junjun Chen Liting Cheng Junmeng Zhang Zefeng Wang Zhuo Liang Jieruo Chen Yongquan Wu Xiao Du Ruiqing Dong Fei Hang Xinlu Wang Ziyu Wang Efficacy and safety of left bundle branch area pacing versus right ventricular apex pacing in patients with atrioventricular block: study protocol for a randomised controlled trial BMJ Open |
| title | Efficacy and safety of left bundle branch area pacing versus right ventricular apex pacing in patients with atrioventricular block: study protocol for a randomised controlled trial |
| title_full | Efficacy and safety of left bundle branch area pacing versus right ventricular apex pacing in patients with atrioventricular block: study protocol for a randomised controlled trial |
| title_fullStr | Efficacy and safety of left bundle branch area pacing versus right ventricular apex pacing in patients with atrioventricular block: study protocol for a randomised controlled trial |
| title_full_unstemmed | Efficacy and safety of left bundle branch area pacing versus right ventricular apex pacing in patients with atrioventricular block: study protocol for a randomised controlled trial |
| title_short | Efficacy and safety of left bundle branch area pacing versus right ventricular apex pacing in patients with atrioventricular block: study protocol for a randomised controlled trial |
| title_sort | efficacy and safety of left bundle branch area pacing versus right ventricular apex pacing in patients with atrioventricular block study protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/11/6/e043603.full |
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