Cardiac Resynchronization Therapy (CRT) in the Early Phase After Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 主要终点
- Non invasive cardiac output after 72 hours CRT (versus control) treatment
研究概览
简要总结
In patients with broad QRS complexes on electrocardiogram (ECG), the delayed electrical activation of the left heart chamber will cause abnormal contraction.This has been shown to be possible to treat by a special pacemaker treatment which includes pacing of the left heart chamber (= CRT treatment).
In this study the researchers will investigate the effect of acute CRT treatment in the early phase after open heart surgery.
详细描述
Patients with bundle branch block have a delayed electrical activation of the left ventricle causing abnormal contractility of the left ventricle.
We hypothesize that patients may benefit from short term (= 72 hours) CRT (Cardiac Resynchronization Therapy) in the early phase after open heart surgery.
Patients: reduced LV function and bundle branch block.
Study type: randomisation to CRT versus standard postoperative treatment
Study variables: cardiac output, echocardiographic measures, p-BNP and hours with inotropic therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for open heart surgery (coronary artery bypass graft [CABG] or mitral valve surgery or aortic valve surgery or combinations of the above mentioned surgical procedures) and LV ejection fraction < 35% and bundle branch block (QRS > 9.12 s)
排除标准
- •Severe right heart failure
- •Permanent atrial fibrillation
- •Congenital heart disease
- •Serious non-cardiac disease
结局指标
主要结局
Non invasive cardiac output after 72 hours CRT (versus control) treatment
次要结局
- Echocardiographic measures of left ventricular (LV) function
- Mixed venous oxygen saturation
- Invasively determined cardiac output
- Plasma brain natriuretic peptide (p-BNP)
- Number of hours with inotropic treatment