Conduction System Pacing Versus Biventricular Pacing for Heart Failure Patients With Right Ventricular Pacing Upgraded to Cardiac Resynchronization Therapy: a Prospective Multicenter Non-inferiority Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- ΔLVEF
研究概览
简要总结
The present study is a prospective, multicenter, non-inferiority, randomized controlled trail. It aims to investigate whether the efficacy of conduction system pacing (CSP) is non-inferior to biventricular pacing (BiVP) in patients with heart failure and right ventricular pacing (RVP) requiring upgrading to cardiac resynchronization therapy (CRT).
详细描述
RVP is a standardized treatment strategy for severe bradyarrhythmia. However, RVP can result in electrical and mechanical dyssynchrony of the heart, which will adversely affect cardiac function. Until now, many studies have shown that RVP can promote the progression of heart failure, especially in patients with high ventricular pacing percentage. For these heart failure patients, upgrading to CRT is a feasible and effective therapy.
BiVP is a traditional method to achieve CRT, which can improve cardiac synchrony and provide great clinical outcomes for heart failure patients upgraded from RVP. CSP contains left bundle branch pacing (LBBP) and His bundle pacing (HBP), which is able to activate native His-Purkinje conduction system and solve the problems caused by RVP. Although HBP has high technical requirements, lower sense value and higher threshold, it is the pacing modality closest to physiological conditions so far. Since first reported by Huang et al. in 2017, LBBP has been carried out boomingly all over the world. LBBP has been reported to offer higher success rate with higher sense value and lower pacing thresholds compared with HBP, which can also achieve similar electrical and mechanical resynchronization as well as HBP.
However, no randomized controlled studies have been reported to compare the efficacy of CSP and BiVP in patients with heart failure and RVP requiring upgrading to CRT. CSP-UPGRADE is a non-inferiority study, and the purpose of which is to investigate whether the efficacy of CSP is not inferior to BiVP in such patients. Eligible patients will be 1:1 randomized to two groups. The primary outcome is change in LVEF between baseline and six months after device implantation assessed by echocardiography. According to BUDAPEST-CRT Upgrade trial, half of lower limit of the 95% confidence interval for difference in mean ΔLVEF between the CRTD and ICD group is about 3.8%, which is used as non-inferiority margin in the present study. Based on previous studies and cases, it is assumed that the mean ΔLVEF values in patients upgraded to CSP and BiVP are equal and the standard deviations are both 5%. With power as 80%, alpha as 0.025, rate of lost-of-follow-up as 10%, the final sample size was estimated as 66 by using PASS Version 21.0.3 (33 patients for each group). If the non-inferiority test reaches positive results, then we will further verify whether CSP is superior to BiVP in such patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic heart failure (LVEF <50%) after right ventricular pacing for at least 3 months;
- •NYHA class II-IV;
- •NT-proBNP >125pg/mL in patients with sinus rhythm, NT-proBNP >250pg/mL in patients with atrial fibrillation;
- •Right ventricular pacing percentage >40%;
- •Adult patients aged 18-80;
- •With informed consent signed.
排除标准
- •History of acute myocardial infarction within 3 months before enrollment;
- •Frequent premature ventricular contraction (>15%) or malignant ventricular arrhythmia which is difficult to control;
- •History of valvular heart disease intervention within 3 months before enrollment;
- •After mechanical tricuspid valve replacement;
- •Ventricular septal hypertrophy (≥15mm during diastole);
- •Complex congenital heart disease;
- •History of heart transplantation;
- •Enrollment in any other study;
- •Pregnant or with child-bearing plan;
- •A life expectancy of less than 12 months.
研究组 & 干预措施
CSP group
In this group, CSP lead is attempted to be placed, including LBBP and HBP.
干预措施: Conduction system pacing (Device)
BiVP group
In this group, traditional RA lead , RV lead and LV lead are attempted to be placed.
干预措施: Biventricular pacing (Device)
结局指标
主要结局
ΔLVEF
时间窗: Baseline; 6-month follow-up
Change in LVEF between baseline and six months after device implantation
次要结局
- ΔLVEDD(Baseline; 3-month follow-up; 6-month follow-up)
- ΔLVEDV(Baseline; 3-month follow-up; 6-month follow-up)
- ΔLVESV(Baseline; 3-month follow-up; 6-month follow-up)
- Paced QRS duration(1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up)
- Echocardiographic response rate(Baseline; 6-month follow-up)
- Changes in New York Heart Association Heart Function Classification(Baseline; 1-month follow-up; 3-month follow-up; 6-month follow-up)
- Pacemaker related complications(1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up)
- Changes in NT-proBNP(Baseline; 3-month follow-up; 6-month follow-up)
- Incidence of clinical adverse events(1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up)
- Changes in 6-minute Walk Distance(Baseline; 3-month, 6-month follow-up)
- Change in Quality Of Life Questionnaire score(Baseline; 3-month follow-up; 6-month follow-up)
- Pacing parameters(1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up)
- Procedure-related costs(1 day before discharge)
- Estimated longevity of the device(1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up)
研究者
Jiangang Zou
Head of Internal Medicine
The First Affiliated Hospital with Nanjing Medical University