His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Ejection Fraction
研究概览
简要总结
The study compares standard right ventricle apical pacing with so called His-bundle pacing, for patients with slightly or moderately reduced ejection fraction and atrioventricular block requiring pacemaker therapy. The primary outcome is left ventricular ejection fraction measured after 6 months.
详细描述
Patients with reduced systolic ejection fraction (40≤ ejection fraction ≤55%) and pacemaker indication due to high degree AV block are included. The study has a randomized double blinded crossover design. Patients are implanted with a standard right ventricle lead and right atrial lead (if indicated), and in addition a His-bundle lead. Randomization is performed as to which pacing modality is used during the first 6 months. After 6 months the pacing modality is changed. Patients are blinded and endpoint adjudicators, including echocardiography staff, are blinded. Device nurse and physician are not blinded.
Primary endpoint is difference in left ventricular ejection fraction after 6 months, paired comparisons are used and each patient is their own control. Secondary endpoints include complications and safety of the device/electrode, and quality of life.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients and outcomes assessors are blinded. Staff involved in device programming are not blinded.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AV block II or III with high expected pacing need
- •Left ventricular ejection fraction between 40% and 55% (inclusive)
- •Willing to participate and sign informed consent
排除标准
- •Under 18 years old
- •Hypertrophic cardiomyopathy
- •Cardiac sarcoidosis
- •Cardiac amyloidosis
- •Previous myocardial infarction within last 3 months
- •Ventricular septum defect or other other left ventricular corrective surgery
- •Congenital heart disease surgically corrected
- •Atrial fibrillation with uncontrolled rate (if not planned for AV node ablation)
结局指标
主要结局
Ejection Fraction
时间窗: 6 months
Absolute difference in left ventricular systolic ejection fraction (absolute percent)
次要结局
- NT-ProBNP(6 months)
- Left Ventricular Activation Time (LVAT)(6 months)
- QRS duration(6 months)
- 6 minute walk test(6 months)
- Adverse events(12 months)
- Change in quality of life measured by the Short Form Health Survey (SF-36) mean score(6 months)
- Left ventricular activation time(6 months)
- Change in quality of life measured by the EuroQol EQ-5D-5L Questionnaire(6 months)