Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial
Introduction Left bundle branch area pacing (LBBaP) has been accepted as a physiological pacing method that can yield narrow paced QRS waves. For patients with failed biventricular pacing (Bi-V), LBBaP is another feasible option. However, no randomised controlled study has evaluated the efficacy and...
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BMJ Publishing Group
2020-09-01
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| author | Lin Zhao Liting Cheng Junmeng Zhang Zefeng Wang Mengge Zhou Zhuo Liang Jieruo Chen Yongquan Wu |
| author_facet | Lin Zhao Liting Cheng Junmeng Zhang Zefeng Wang Mengge Zhou Zhuo Liang Jieruo Chen Yongquan Wu |
| author_sort | Lin Zhao |
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| description | Introduction Left bundle branch area pacing (LBBaP) has been accepted as a physiological pacing method that can yield narrow paced QRS waves. For patients with failed biventricular pacing (Bi-V), LBBaP is another feasible option. However, no randomised controlled study has evaluated the efficacy and safety of LBBaP in heart failure patients with left bundle branch block (LBBB). Therefore, we aimed to conduct this type of randomised controlled trial.Methods and analysis This study is a single-centre, randomised controlled non-inferiority trial. This study will be conducted at the cardiac centre of Beijing Anzhen Hospital. From January 2020 to December 2022, 180 heart failure patients with reduced left ventricular ejection fraction (LVEF ≤35%) and LBBB undergoing Bi-V implantation will be consecutively enrolled in this study. Participants will be randomised at a 1:1 ratio into an experimental group (LBBaP) and a control group (Bi-V). The primary outcome is LVEF. The secondary outcomes are NT-proBNP, duration of the QRS complex, end systolic volume, end diastolic volume, the 6-minute walking test and quality of life (SF-36 scale), all causes of mortality, cardiovascular death, rehospitalisation rate of heart failure, other rehospitalisation rates, major complication rates, procedure costs and hospitalised dates.Ethics and dissemination This study has been approved by the Beijing Anzhen Hospital Medical Ethics Committee (No. ks201932). The results of this study will be presented at domestic and international conferences. We hypothesise that LBBaP is non-inferior compared with Bi-V for treating patients with heart failure and LBBB. This trial will provide evidence-based recommendations for electrophysiologists.Trial registration number Chinese Clinical Trial Registry (ChiCTR2000028726). |
| format | Article |
| id | doaj-art-a485bbd6950743729bb311776bb5d757 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-a485bbd6950743729bb311776bb5d7572025-08-20T01:48:33ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-036972Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trialLin Zhao0Liting Cheng1Junmeng Zhang2Zefeng Wang3Mengge Zhou4Zhuo Liang5Jieruo Chen6Yongquan Wu7Liaoning Key Laboratory of molecular targeted anti-tumor drug development and evaluation; Liaoning Cancer immune peptide drug Engineering Technology Research Center; Key Laboratory of Precision Diagnosis and Treatment of Gastrointestinal Tumors, Ministry of Education, China Medical University, Shenyang, ChinaBeijing An Zhen Hospital, Chaoyang-qu, ChinaDepartment of Cardiology, Beijing An Zhen Hospital, Chaoyang-qu, Beijing, ChinaDepartment of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, ChinaVanke School of Public Health, Tsinghua University, Beijing, People`s Republic of ChinaBeijing An Zhen Hospital, Chaoyang-qu, ChinaBeijing An Zhen Hospital, Chaoyang-qu, ChinaBeijing An Zhen Hospital, Chaoyang-qu, ChinaIntroduction Left bundle branch area pacing (LBBaP) has been accepted as a physiological pacing method that can yield narrow paced QRS waves. For patients with failed biventricular pacing (Bi-V), LBBaP is another feasible option. However, no randomised controlled study has evaluated the efficacy and safety of LBBaP in heart failure patients with left bundle branch block (LBBB). Therefore, we aimed to conduct this type of randomised controlled trial.Methods and analysis This study is a single-centre, randomised controlled non-inferiority trial. This study will be conducted at the cardiac centre of Beijing Anzhen Hospital. From January 2020 to December 2022, 180 heart failure patients with reduced left ventricular ejection fraction (LVEF ≤35%) and LBBB undergoing Bi-V implantation will be consecutively enrolled in this study. Participants will be randomised at a 1:1 ratio into an experimental group (LBBaP) and a control group (Bi-V). The primary outcome is LVEF. The secondary outcomes are NT-proBNP, duration of the QRS complex, end systolic volume, end diastolic volume, the 6-minute walking test and quality of life (SF-36 scale), all causes of mortality, cardiovascular death, rehospitalisation rate of heart failure, other rehospitalisation rates, major complication rates, procedure costs and hospitalised dates.Ethics and dissemination This study has been approved by the Beijing Anzhen Hospital Medical Ethics Committee (No. ks201932). The results of this study will be presented at domestic and international conferences. We hypothesise that LBBaP is non-inferior compared with Bi-V for treating patients with heart failure and LBBB. This trial will provide evidence-based recommendations for electrophysiologists.Trial registration number Chinese Clinical Trial Registry (ChiCTR2000028726).https://bmjopen.bmj.com/content/10/9/e036972.full |
| spellingShingle | Lin Zhao Liting Cheng Junmeng Zhang Zefeng Wang Mengge Zhou Zhuo Liang Jieruo Chen Yongquan Wu Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial BMJ Open |
| title | Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial |
| title_full | Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial |
| title_fullStr | Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial |
| title_full_unstemmed | Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial |
| title_short | Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial |
| title_sort | efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block study protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/10/9/e036972.full |
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