scholarly journals 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 ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036972
Author(s):  
Liting Cheng ◽  
Junmeng Zhang ◽  
Zefeng Wang ◽  
Mengge Zhou ◽  
Zhuo Liang ◽  
...  
Keyword(s):  
Heart Failure ◽  
Randomised Controlled Trial ◽  
Left Bundle Branch Block ◽  
Controlled Trial ◽  
Biventricular Pacing ◽  
Left Ventricular Ejection ◽  
Efficacy And Safety ◽  
Bundle Branch Block ◽  
Heart Failure Patients ◽  
Randomised Controlled

IntroductionLeft 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 analysisThis 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 disseminationThis 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 numberChinese Clinical Trial Registry (ChiCTR2000028726).

scholarly journals Comparison of efficacy and safety of His-Purkinje system pacing versus cardiac resynchronisation therapy in patients with pacing-induced cardiomyopathy: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e045302
Author(s):  
Junjun Chen ◽  
Liting Cheng ◽  
Zefeng Wang ◽  
Zhuo Liang ◽  
Ruiqing Dong ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cardiac Resynchronisation Therapy ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Efficacy And Safety ◽  
Purkinje System ◽  
Cardiac Resynchronisation ◽  
Resynchronisation Therapy ◽  
Randomised Controlled

IntroductionRecent studies have shown that the His-Purkinje system pacing (HPSP) can achieve electrocardiomechanical synchronisation, and thus improve cardiac function. For patients with pacing-induced cardiomyopathy (PICM) who should be treated with pacemaker upgrade, the HPSP is a viable alternative to cardiac resynchronisation therapy (CRT). However, no randomised controlled trial has been performed to evaluate the efficacy and safety of HPSP in patients with PICM. The present study compared the efficacy and safety of HPSP with that of traditional CRT in the treatment of patients with PICM.Methods and analysisThis study is a single-centre, randomised controlled non-inferiority trial. This trial was carried out at the cardiac centre of Beijing Anzhen Hospital. A total of 46 patients with PICM who needed pacemaker upgrade treatment between January 2022 and December 2023 will be enrolled in this study. Patients will be randomised into an investigational group (HPSP) and a control group (CRT) at a 1:1 ratio. The primary outcome is the duration of QRS complex (QRS width), and the secondary outcomes are NT-proBNP (N terminal pro B type natriuretic peptide), C reactive protein, the number of antibiotics used, left ventricular ejection fraction, end systolic volume, end diastolic volume, the hospitalisation duration, the incidence of postoperative infection, pacemaker parameters (threshold, sensing and impedance), the 6-minute walking test, and quality of life (36-Item Short Form Survey scale), all-cause mortality, cardiovascular death, heart failure-related rehospitalisation rate, other rehospitalisation rates, major complication rates and procedure costs.Ethics and disseminationThis study has been approved by the Beijing Anzhen Hospital Medical Ethics Committee (No. 2020043X).Trial registration numberChinese Clinical Trial Registry (ChiCTR2000034265).

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