Pacing-induced Cardiomyopathy - the Importance of Right Ventricular Pacing Site and Patterns of Dyssynchronous Myocardial Activation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Pacing-induced cardiomyopathy
研究概览
简要总结
This study will evaluate the association between right ventricular pacing and the risk of pacing-induced cardiomyopathy.
详细描述
Background:
Right ventricular (RV) pacing may lead to pacing-induced cardiomyopathy (PICM) and heart failure (HF). The detrimental effects of RV pacing have been attributed to the abnormal and dyssynchronous electrical and mechanical activation of the myocardium. The activation is affected by the RV pacing site. Understanding the consequences of different RV pacing sites and the patterns of dyssynchrony may help to choose the optimal treatment for the individual patient.
Aim and objectives:
The overall aim of this project is to investigate the association between RV pacing site and the risk of PICM. Contrast enhanced cardiac computed tomography (CT) will be applied for precise localization of the RV pacing. Furthermore, investigation of the association between PICM and different mechanical and electrical myocardial activation patterns during RV pacing will be conducted using new echocardiographic and electrocardiographic methods.
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years
- •De novo DDD PM implanted at Aalborg University Hospital
- •PM implantation due to advanced AV block
- •Duration of pacemaker treatment ≥ 1 year at time of screening
- •Normal LVEF (≥50%) prior to PM implantation
- •Actively attending follow-up at the PM outpatient clinic at Aalborg University Hospital after PM implantation
排除标准
- •No written informed consent
- •Baseline TTE not available or insufficient quality for assessment of LVEF
- •Contraindications to a new contrast CT if no previous contrast-enhanced cardiac CT, showing RV lead position, is available
- •RV pacing load < 40%.
- •Not attending follow-up at the PM outpatient clinic at Aalborg University Hospital after PM implantation
- •Device complications with removal of original implanted pacing lead > 3 months after primary implantation
- •Subjects with severe ischemic heart disease and severe valvular heart disease.
- •Terminal illness or unable to provide informed consent at time of screening
结局指标
主要结局
Pacing-induced cardiomyopathy
时间窗: After ≥ 1 years of exposure to right ventricular pacing
Time to development of PICM. PICM is defined as ≥ 10% decrease in LVEF resulting in LVEF \< 50% after pacemaker implantation.
次要结局
- Change in LVEF(After ≥ 1 year of exposure to right ventricular pacing)
- Change in LV end-diastolic volume(After ≥ 1 years of exposure to right ventricular pacing)
- Change in LV end-systolic volume(After ≥ 1 years of exposure to right ventricular pacing)
- Composite endpoint of new-onset heart failure(After ≥ 1 year of exposure to right ventricular pacing)
- New-onset atrial fibrillation and/or atrial flutter(After ≥ 1 years of exposure to right ventricular pacing)
研究者
Patricia Fruelund
MD, clinical assistant, PhD student
Aalborg University Hospital