His Bundle Pacing Versus Right Ventricular Pacing: a Randomized Crossover Study (His-PACE)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Left ventricular ejection fraction
研究概览
简要总结
This study will randomize cross-over periods of 6 months of right ventricular pacing and His bundle pacing in patients with baseline left ventricular ejection fraction (LVEF)>40%. The primary outcome measure is LVEF.
详细描述
Monocentric, randomized, double-blind comparative crossover clinical study.
Patients with a standard pacing indication with >20% ventricular pacing, with a baseline LVEF >40%, implanted with a functioning His bundle lead and a backup right ventricular lead, will be randomized to 6-months periods of right ventricular pacing and of His bundle pacing. The primary outcome is LVEF assessed by gated Equilibrium Radionuclide Angiography. Secondary outcomes are diastolic function, New York Heart Association (NYHA) functional class, quality of life, 6-minute walk test, heart failure hospitalisations and device electrical parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Baseline LVEF>40%
- •Standard pacing indication with >20% VP
- •Functional His bundle lead with confirmed His capture
- •Functional right ventricular lead with myocardial capture
排除标准
- •Unable to sign an informed consent form
结局指标
主要结局
Left ventricular ejection fraction
时间窗: 6 months
Assessed by gated Equilibrium Radionuclide Angiography
次要结局
- Hospital admission for cardiovascular causes(up to 6 months)
- Left ventricular peak filling rate (EDV/s)(6 months)
- NYHA functional class(6 months)
- 6-minute walk test(6 months)
- Quality of life measure by SF-36 questionnaire(6 months)
- Right ventricular ejection fraction(6 months)
研究者
Haran Burri, MD
Professor
University Hospital, Geneva