Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 486
- 试验地点
- 8
- 主要终点
- The primary endpoint is the time to a first event of composite outcomes, including all-cause death, hospitalization for heart failure, and an upgrade to cardiac resynchronization therapy due to pacing induced heart failure.
研究概览
简要总结
This is a multicenter, randomized controlled study. The aim of this study is to compare the impact of LBBAP on left ventricular function as compared with traditional right ventricular pacing in patients with atrioventricular block.
详细描述
LEAP-BLOCK is a prospective, multi-center, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may reduce the risk of RV ventricular pacing induced cardiac dysfunction as compared with traditional RV pacing (RVP) in patients with atrioventricular (AV) block and normal LV function (LVEF≥50%) who require high percent of ventricular pacing. The primary aim of this trial is to compare the time to first event (composite of all-cause mortality and newly heart failure hospitalization and device upgrade due to heart failure) between LBBAP and RVP group in patients with AV block. Patients with AV block and normal LV function who require high burden of ventricular pacing (expected >40%) will be randomized to LBBAP or RVP group for therapy. Patients will be followed at least every 3 months for clinical status and every 6 months for echocardiographic evaluation until the study closure.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a. Adult patients aged 18-90;
- •b. AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)> 40%, including (a)Third-degree AV block; (b) Second degree AV block (type II); (c) intermittent advanced AV block with expected VP>40%; (d)Symptomatic first degree AV block and PR interval on ECG ≥ 250ms;
- •c. The subject is able to receive a pectoral implant;
- •d. The subject is willing and able to comply with the protocol;
- •e. The subject is expected to remain available for follow-up visits at the study centers.
- •f. Subject or authorized legal guardian or representative has signed and dated the study Subject Informed Consent
排除标准
- •a. Baseline echocardiographic assessment of patients with impaired LV function (LVEF<50%);
- •b. Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons;
- •c. Patients with persistent atrial fibrillation;
- •d. Pacemaker replacement without new implanted ventricular electrodes;
- •e. Patients with implantable cardioverter-defibrillator (ICD) indications;
- •f. Surgery is required within 1 year due to severe structural heart disease;
- •g. Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc), or AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM)vpost (modified) Morrow surgery, (b) ventricular septal defect repair; and those who are unlikely to achieve successful LBBAP procedure.
结局指标
主要结局
The primary endpoint is the time to a first event of composite outcomes, including all-cause death, hospitalization for heart failure, and an upgrade to cardiac resynchronization therapy due to pacing induced heart failure.
时间窗: Within two years after device implantation
All-cause death: including cardiovascular and non-cardiovascular deaths. Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy. Upgrade to cardiac resynchronization therapy (CRT): Upgrade from dual-chamber pacemaker to CRT-Pacemaker/CRT-Defibrillator due to impaired LV function (LVEF decrease to 40% or less).
次要结局
- Rate of the composite outcomes of all-cause death and/or hospitalization for heart failure(Within 2 years after device implantation)
- The time to a first event of LVEF <50% and decrease in LVEF by ≥ 10% during 2 years follow-up as compared with the value at randomization.(24 months)
- Atrial high-rate episodes recorded by the pacemaker(24 months)
- Rate of the composite outcomes of hospitalization for heart failure and/or an upgrade to cardiac resynchronization therapy due to pacing induced heart failure.(Within 2 years after device implantation)
- The occurrence of LV dyssynchrony(24 months)
- Rate of the composite outcomes of LVEF <50%, and/or an increase in LVESV ≥15% during follow-up as compared with the value at randomization(Within 2 years after device implantation)
- The value of LVEF and LVESV assessed by echocardiography at 1-year and 2-year follow-up(24 months)
- The immediate success rate of the LBBAP procedure(1 weeks)
- The rate of procedure and Device related complications(24 months)
- Changes in Pacing parameters and ECG characteristics.(24 months)
- The long-term success rate of LBBAP(24 months)
研究者
Xiaohan Fan
Professor, MD, PhD
Chinese Academy of Medical Sciences, Fuwai Hospital