Left Bundle Area Pacing Vs. Right Ventricular Pacing in Patients With Normal Left Ventricular Function -The Boston Pace Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in left ventricular ejection fraction (LVEF)
研究概览
简要总结
Right ventricular (RV) pacing can cause left ventricular systolic dysfunction in 10- 20% of patients. Biventricular pacing had previously been shown to prevent left ventricular systolic dysfunction. However, implantation of coronary sinus lead increases procedural risk and can be limited by higher threshold and phrenic nerve capture. HIS pacing has been evaluated as an alternative pacing strategy, but its routine use was limited by difficulty of the procedure, success rate and high pacing threshold.
Left bundle branch area pacing (LBBAP) is a promising physiologic pacing technique that has been proposed as a pacing strategy to prevent pacing induced cardiomyopathy and for treatment of desynchrony in heart failure. LBBAP has been adopted widely and performed routinely on patients with AV block. Currently, it is up to the discretion of the proceduralist whether LBBAP is performed given that there is lack of evidence to guide pacing strategies.
详细描述
This pilot trial is a feasibility study that will assess for efficacy, safety and success rate of left bundle branch area pacing. The study will also examine the recruitment rate at 2 major tertiary hospitals.
The study will examine if the use of LBBAP can prevent the occurrence of pacing induced cardiomyopathy (PICM) compared to RV pacing among patients with normal left ventricular function and high-grade AV block.
The investigators hypothesize that the rate of pacing induced cardiomyopathy is lower with LBBAP compared to RV pacing in patients with normal left ventricular function requiring high burden of RV pacing.
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
- Single (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
- •Patients with complete AV block, high-grade AV block with an anticipated ventricular pacing rate of more than 40%
- •Left ventricular ejection fraction of 50% or more.
- •Echocardiogram within the last 3 months
排除标准
- •History of systolic dysfunction with LV EF of less than 50%
- •Prior myocardial infarction
- •Obstructive coronary artery disease
- •Severe valvular dysfunction
- •Life expectancy of less than a year
研究组 & 干预措施
Left Bundle Branch Area Pacing
干预措施: Left Bundle Branch Area Pacemaker (Device)
Right Ventricular Pacing
干预措施: Right Ventricular Pacemaker (Device)
结局指标
主要结局
Change in left ventricular ejection fraction (LVEF)
时间窗: 12 months
Change in left ventricular end systolic volume (LVESV)
时间窗: 12 months
次要结局
- Success rate of LBBAP(30 days)
- All-cause mortality(12 months)
- Cardiovascular mortality(12 months)
- Rate of heart failure related visit: defined as heart failure hospitalization or emergency room visit or urgent visit requiring intravenous heart failure therapy(12 months)
- Number of participants with upgrade to cardiac resynchronization therapy(12 months)
- New York Heart Association Class I-IV (IV is worst)(12 months)
- Number of participants with occurrence of moderate or severe tricuspid regurgitation on echocardiogram(12 months)
- Number of participants with occurrence of moderate or severe mitral regurgitation on echocardiogram(12 months)
- Number of participants with new onset atrial fibrillation(12 months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ-12) (score of 8-40)(12 months)
- Paced QRS duration on 12 lead EKG(Evaluated at 1 day, 30 days and 12 months)
- Pacing percentage(12 months)
- Complication rate including pneumothorax, cardiac tamponade, infection, and lead revision(12 months)
- Procedure time(1 day)
- Fluoroscopy time(1 day)
- Pacing capture threshold (V)(12 months)
- R wave amplitude (mV)(12 months)
- RV lead impedance (ohms)(12 months)
研究者
Shaan Khurshid
Principal Investigator
Massachusetts General Hospital