Impact of Left Ventricular Pacing on Left Ventricular Systolic Function in High-risk Bradycardia Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Left ventricular ejection fraction (%) at 12 months
研究概览
简要总结
In this study, the investigators will examine whether left ventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients with bradycardia with high risk for development of pacing-induced heart failure.
详细描述
In this prospective, we will randomly assign 98 patients who need permanent pacemaker due to complete atrioventricular block or sick sinus syndrome to receive left ventricular pacing (49 patients) or right ventricular apical pacing (49 patients). Patients will be paced with temporary pacemaker lead, and only those with paced QRS duration ≥185 ms will be enrolled.
The primary endpoint is left ventricular ejection fraction measured by modified Simpson method at 12 months. The secondary end points include left ventricular systolic end-systolic and diastolic volume, LV strain, NYHA functional class, exercise performance (using treadmill test), quality of life (using SF-36v2), NT-proBNP at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sinus-node dysfunction or bradycardia due to advanced atrioventricular block
- •Paced QRS duration ≥185 ms
排除标准
- •Left ventricular ejection fraction < 50 %
- •Acute coronary syndrome
- •If they had undergone percutaneous coronary intervention or coronary-artery bypass surgery within the previous 3 months
- •if they had a life expectancy of less than 1 year
- •if they had received a heart transplant
结局指标
主要结局
Left ventricular ejection fraction (%) at 12 months
时间窗: 12 months
Measured by modified Simpson's method
次要结局
- NYHA functional class(12 months)
- NT-proBNP(12 months)
- Left ventricular end-systolic volume (ml) at 12 months(12 months)
- Functional capacity(12 months)
- Left ventricular end-diastolic volume (ml) at 12 months(12 months)
研究者
Seil Oh
Dr.
Seoul National University Hospital