Protection on Cardiac Function With Left Bundle Branch Pacing in Patients With Atrioventricular Block(OptimPacing)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 683
- 试验地点
- 1
- 主要终点
- A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)
研究概览
简要总结
OptimPacing study has been designed as a prospective, multi-center, randomized, controlled trial. A total of 11 medical centers across China will enroll 683 patients over an estimated recruitment period of 2 years. An LBBP group will be compared with a group of conventional RVP in the follow-up of at least 3 years. The study aimed to demonstrate (1) the superiority of LBBP in preserving LV systolic function over RVP and (2) the feasibility and long-term safety of LBBP in patients with AV block.
详细描述
Introduction
Right ventricular pacing (RVP) has been the standard-of-care therapy for patients with bradycardia for sixty years. However, the selection of optimal pacing site is still controversial. Right ventricular septal or outflow tract pacing has not resulted in improved outcomes. RVP is considered to result in electrical and mechanical dyssynchrony and an increased risk of pacing-induced cardiomyopathy (PICM), heart failure and mortality. Biopace (Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization) study is a randomized controlled trial with a large population evaluating biventricular pacing versus RVP in patients with atrioventricular (AV) block. But biventricular pacing was not shown superiority in clinical outcomes compared with RVP. As biventricular pacing is delivered at two non-physiological sites, it actually creates ventricular dyssynchrony in patients with narrow QRS durations. Thus, seeking for the optimal pacing site has been the ultimate goal of doctors who specialize in cardiac pacing.
His-bundle pacing (HBP) is thought to be the most physiological pacing modality, which was initial applied by Deshmukh et al in 2000. HBP activates native His-Purkinje system and produces favorable electrical and mechanical synchrony. Clinical observations have shown HBP could reduce the incidence of PICM and improve combined clinical outcomes. However, HBP is not widely applied because of challenging operating techniques, unstable long-term pacing parameters and risk of loss of ventricular capture in a significant number of patients.
Left bundle branch pacing (LBBP) was first introduced by Huang et al in 2017. Since then, LBBP has been carried out boomingly in China. Similar with HBP, LBBP could activate left bundle branch (LBB) fibers and provide narrower paced QRS duration and better left ventricular (LV) mechanical synchrony than RVP. Animal studies also confirmed the physiological characteristics and anatomical lead locations of LBBP. Several clinical studies showed that LBBP could produce significantly narrower paced QRS duration and better echocardiographic response than biventricular pacing in patients with heart failure and LBB block. Furthermore, the implantation procedure appears easier and capture threshold is lower when compared with HBP. LBBP has appeared to be a promising approach in the clinical practice. However, no randomized controlled studies have been reported to compare the efficacy of LBBP and other pacing modalities.
Objectives
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication of permanent pacemaker implantation: (1) Second degree or complete AV block; (2) Persistent or permanent atrial fibrillation with mean ventricular rate < 50 bpm and related symptoms
- •LVEF > 35%, NYHA classification I-III
- •Age > 18 years
- •Signed informed consent
排除标准
- •Implanted prosthetic tricuspid valve
- •Unstable angina, acute myocardial infarction, CABG or PCI within the last 3 months
- •Cardiac surgery like valvular replacement, TAVI, ventricular septal myectomy or ablation within the last 3 months
- •Enrolled in any other study
- •A life expectancy of less than 12 months or unable to undergo the planned
- •follow-up for any reasons
- •Pregnant or with a child-bearing plan
- •A history of heart transplantation
- •Complex congenital heart disease (whether surgical correction or not) and post-surgery repair or post-closure of ventricular septal defect
- •Ventricular septal hypertrophy (≥ 15mm during diastole)
- •Isolated persistent left superior vena cava
- •With ICD, CRT or CRTD indications
- •Pacemaker replacement, upgrade and pocket infection needing re-implantation
研究组 & 干预措施
LBBP group
In this arm, a left bundle branch pacing(LBBP) lead is attempted to be placed.
干预措施: Left bundle branch pacing (Procedure)
RVP group
In this arm, a right ventricular pacing(RVP) lead are placed.
干预措施: Right ventricular pacing (Procedure)
结局指标
主要结局
A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)
时间窗: 36-month follow-up
Incidence of all-cause death, hospitalization for HF and/or PICM
次要结局
- Left ventricular ejection fraction(LVEF)(Baseline; 6-month, 12-month, 24-month and 36-month follow-up)
- Left ventricular end systolic volume(LVESV)(Baseline; 6-month, 12-month, 24-month and 36-month follow-up)
- Changes in concentration of NT-proBNP in blood between baseline and follow-up(Baseline; 6-month,12-month, 24-month and 36-month follow-up)
- Left ventricular end diastolic volume(LVEDV)(Baseline; 6-month, 12-month, 24-month and 36-month follow-up)
- Left ventricular end systolic diameter(LVESD)(Baseline; 6-month, 12-month, 24-month and 36-month follow-up)
- Septal-to-posterior wall motion delay(SPWMD)(Baseline; 6-month, 12-month, 24-month and 36-month follow-up)
- Changes in New York Heart Association Heart Function Classification between baseline and follow-up(Baseline; 6-month,12-month, 24-month and 36-month follow-up)
- Changes in 6-minute Walk Distance between baseline and follow-up(Baseline; 6-month,12-month, 24-month and 36-month follow-up)
- Change in Quality Of Life Questionnaire score between baseline and follow-up(Baseline; 6-month,12-month, 24-month and 36-month follow-up)
- Pacing parameters(Before discharge; 1-month, 3-month, 6-month, 12-month, 24-month and 36-month follow-up)
- Left ventricular end diastolic diameter(LVEDD)(Baseline; 6-month, 12-month, 24-month and 36-month follow-up)
- Interventricular movement time difference(IVMD)(Baseline; 6-month, 12-month, 24-month and 36-month follow-up)
- Incidence of other clinical adverse events(6-month, 12-month, 24-month and 36-month follow-up)