Catheter Ablation vs. Medical Treatment in Patients With HFrEF and Persistent AF (CAEFR-AF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Difference in ejection fraction between groups
研究概览
简要总结
This is an open label, multi-center, randomized parallel control clinical trial, to examining thethe clinical outcomes of AF ablation on HFrEF patients with persistent atrial fibrillation.
详细描述
This is an open label, multi-center, randomized parallel control clinical trial. HFrEF patients with persistent atrial fibrillation are 1:1 randomized into the AF ablation group or the medical therapy (rate or rhythm control) group. Markers of HFrEF severity, including composite of death from any cause or worsening of heart failure that led to an unplanned overnight hospitalization,exercise hemodynamics, natriuretic peptide levels, and patient symptoms. and other indicators are analyzed to demonstrate the role of AF ablation in comparing the effects of AF ablation vs usual medical therapy for HFrEF patients with persistent atrial fibrillation.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic persistent atrial fibrillation Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs Left Ventricular Ejection Fraction <= 40% NYHA >= II Patient is willing and able to comply with the protocol and has written informed consent Age >= 18 years Optimal therapy for HF of ≥6 weeks Suitable candidate for catheter ablation or rate control for the treatment of AF N-terminal pro-B-type natriuretic peptide (NT-proBNP)/BNP levels above predetermined levels based on prior hospitalization and baseline rhythm
排除标准
- •LA dimension >6.0 cm Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrollment Untreated hypothyroidism or hyperthyroidism Enrollment in another investigational drug or device study Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age Mental or physical inability to take part in the study Severe aortic or mitral valve disease Life expectancy <1 year
结局指标
主要结局
Difference in ejection fraction between groups
时间窗: Time Frame: 12 months
Difference in left ventricular ejection fraction between groups on echocardiography at 12 months
次要结局
- Difference in BNP between groups(Time Frame: 12 months)
- Difference in SR survival between groups(Time Frame: 12 months)
- Difference in NYHA class between groups(Time Frame: 12 months)
- Worsening heart failure requiring unplanned hospitalization(Time Frame: 12 months)
- Change in 6-minute walk distance(Time Frame: 12 months)