LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy: the LEAP-CAR Prospective, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Absolute and relative value of LVEF (left ventricular ejection fraction) difference between two arms at follow-up
研究概览
简要总结
LEAP-CAR will evaluate the benefit of left bundle branch area pacing (LBBAP), comparing to conventional right ventricular pacing (RVP), in preventing pacing-induced cardiomyopathy (PICM) in patients undergoing pacemaker implant for advanced (2° or 3° degree) atrioventricular block, with baseline left ventricular ejection fraction (LVEF) >45%.
LEAP-CAR is a randomized, prospective, double blind clinical trial.
详细描述
Pacing induced cardiomyopathy (PICM) is the deleterious effect of right ventricular (RV) pacing in patients receiving a permanent cardiac pacemaker (PM) for bradycardia. It is usually defined as a decrease in left ventricular (LV) function, generally expressed as ejection fraction (EF) decline, and it is mostly explained by the abnormal electrical and mechanical biventricular activation sequence induced by RV pacing. Several studies reported an incidence of PICM ranging from 10-20% of patients after 2-4 years of at least 20% RV pacing burden and reported an increase in heart failure (HF) and hospitalization in such patients.
Permanent His Bundle Pacing (HBP) maintains normal electromechanical biventricular activation by means of the intrinsic conduction system and is therefore considered in patients with EF >40% and anticipated >20% of ventricular pacing, and may be used as an alternative to CRT in case of "ablate and pace" therapy for uncontrolled supraventricular arrhythmias.
Left bundle branch area pacing (LBBAP) is a novel way to pace the conduction system of the heart, overcoming the drawbacks of HBP (suboptimal electrical measures, increased procedural and fluoroscopy time, loss of conduction system capture at follow-up). Evidence is building in adopting LBBAP instead of conventional CRT; LBBAP may have the potential to avoid PICM in patients needing permanent pacing for bradycardia.
Aim of our study is to assess if LBBAP prevents PICM in patients with preserved EF needing RV pacing for advanced atrioventricular block (AVB).
STUDY DESIGN
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- •advanced AVB (frequent 2° degree or 3° degree AVB, atrial fibrillation - AF - with advanced AV block) and preserved or slightly reduced LVEF (>45%)
排除标准
- •LVEF ≤45%
- •signs or symptoms of heart failure at enrollment
- •unstable angina or acute coronary syndrome <3 months
- •percutaneous coronary intervention or coronary-artery bypass surgery <3 months
- •life expectancy <6 months
- •previous hospitalization for heart failure
- •evidence of pulmonary artery hypertension of any origin
- •valvular disease greater than moderate
- •previous heart transplant pregnancy
结局指标
主要结局
Absolute and relative value of LVEF (left ventricular ejection fraction) difference between two arms at follow-up
时间窗: 1 year
comparison of LVEF by transthoracic echocardiography at 12 months between the two arms (LBBAP vs RV pacing).
次要结局
- Distance covered at 6'WT (meters)(1 year)
- evolution of atrioventricular valves regurgitation(1 year)
- Score of quality of life (n: Higher value = worst outcome)(1 year)
- success rate(1 year)
- Intra-patient evolution of LVEF(1 year)
- Intra-patient evolution of 6'WT (meters difference)(1 year)
- Intra-patient evolution of quality of life(1 year)
研究者
Gabriele Dell'Era
Chief of Electrophysiology Unit
Azienda Ospedaliero Universitaria Maggiore della Carita