Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Recent studies have shown that chronic stimulation of the right ventricle can cause deleterious effects to cardiac function and synchronicity. The occurrence and consequences of this phenomenon in children and young patients with cardiac pacemaker due to advanced atrioventricular block (AVB) are still unknown.
Thus, our aims is to assess the chronic effects of cardiac pacing in children and young patients with advanced AVB and its impact on clinical, functional and echocardiographic parameters.
详细描述
This is a prospective cohort study that will include patients younger than 18 years-old at initial pacemaker implantation due to advanced AVB.
The design of the study will involve the following stages:
- Screening and enrollment: patients will be selected consecutively during ambulatory care at our Institution or by the database of the Surgical Unity of Cardiac Pacing;
- Clinical and laboratory evaluation: patient history, clinical evaluation, serum levels of neurohormonal and inflammatory biomarkers of heart failure, clinical and laboratory investigation of autoimmune rheumatic diseases, quality of life (SF-36, CHQ-PF50) and six-minute walk test;
- Evaluation of ventricular function and cardiac synchronicity: Tissue Doppler (TDI) and real-time three-dimensional echocardiography (RT3DE);
- Follow-up: patients will be monitored during 24 months.
The main end-points are:
- Clinical and functional changes (NYHA functional class)
- Heart failure hospitalization
- Quality of life
- Overall and cardiac mortality
- Cardiac resynchronization therapy and heart transplantation
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age <18 years at initial pacemaker implantation
- •Advanced AV block with /without congenital heart defects
- •Time under cardiac pacing superior than one year
- •Unicameral or atrioventricular pacing in single right ventricle site
- •Informed consent of the patient or responsible
排除标准
- •Bifocal or biventricular pacing
- •Discontinuing use of the device for recovery of atrioventricular conduction
- •Cardiac transplantation
- •Inability to participate in the study procedures
结局指标
主要结局
Mortality
时间窗: 24 months after enrollment
次要结局
- Echocardiogram and Clinical Composite(baseline and 24 months after enrollment)
研究者
Roberto Costa
Associated Professor of Cardiovascular Surgery
University of Sao Paulo