Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 326
- 试验地点
- 6
- 主要终点
- Pacing-induced cardiomyopathy
研究概览
简要总结
Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction >50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages.
Patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.
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
- Single (Participant)
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
- •First implant of a single-chamber or dual chamber pacemaker due to persistent bradycardia associated with high degree atrio-ventricular (AV) block (complete AV block or second degree type II AV block), with second-degree type I AV block (symptomatic or associated with intra-hisian or infra-hisian block), or with atrial fibrillation with symptomatic slow ventricular rate (<45lpm).
- •LVEF>50% at echocardiography performed maximum 7 days before pacemaker implant.
- •Informed consent signature.
排除标准
- •Life expectancy <12 months
- •Severe cardiac valvular abnormality requiring intervention
- •Unstable Angina, Acute myocardial infarction, coronary revascularization, valvular surgery or valvular percutaneous intervention in the 90 days prior to pacemaker implant.
- •Inclusion in another trial which may influence the results of this study.
研究组 & 干预措施
deep
The ventricular lead will be penetrated into the basal interventricular septum aiming at left septal pacing and, if not possible, at least deep septal pacing with a paced QRS duration <=140ms.
干预措施: Pacemaker implant (Device)
Apex
The ventricular lead will be placed in the right ventricular apex.
干预措施: Pacemaker implant (Device)
结局指标
主要结局
Pacing-induced cardiomyopathy
时间窗: 12 months
Decrease in the left ventricular ejection fraction (LVEF) by \>10% as compared to the LVEF before pacemaker implant and final LVEF\<45%.
次要结局
- New York Heart Association (NYHA) class(12 months)
- heart failure(12 months)
- LVEF during follow-up(12 months)
- Mitral and tricuspid regurgitation(12 months)
- Brain Natriuretic Peptide levels(12 months)
研究者
Andrea Di Marco
Principal Investigator
Institut d'Investigació Biomèdica de Bellvitge