Catheter Ablation Versus Medical Treatment of AF in Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Difference in Ejection Fraction Between Groups
研究概览
简要总结
Heart failure and atrial fibrillation (AF) often coexist, and each increases the morbidity and mortality associated with the other. The investigators hypothesized that restoration of normal sinus rhythm by catheter ablation is superior to medical treatment of AF in heart failure. This study randomizes patients with heart failure and persistent AF to medical treatment of AF or catheter ablation to restore sinus rhythm.
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
- •Persistent atrial fibrillation
- •Symptomatic heart failure
排除标准
- •Reversible causes of heart failure
- •Contraindications to catheter ablation
研究组 & 干预措施
Catheter Ablation
Catheter ablation of persistent atrial fibrillation to restore normal sinus rhythm.
干预措施: Catheter ablation of persistent atrial fibrillation (Procedure)
Medical treatment alone
Patients are randomised to medical treatment alone for atrial fibrillation. Treatment will be as per current guidelines for persistent atrial fibrillation, with rate control as first line (using beta-blockers, calcium channel blockers and digoxin as indicated) and rhythm control as second line (using sotalol, dronedarone, or amiodarone as indicated). (Both groups will receive standard heart failure medication including angiotensin converting enzyme inhibitors, beta blockers, aldosterone antagonists, and diuretics as indicated).
干预措施: Medical treatment alone (Drug)
结局指标
主要结局
Difference in Ejection Fraction Between Groups
时间窗: 6 months
Difference in left ventricular ejection fraction between groups on echocardiography at 6 months
次要结局
- Difference in Peak VO2 Between Groups(6 months)
- Difference in NYHA Class Between Groups(6 months)
- Difference in BNP Between Groups(6 months)
- Difference in Quality of Life Between Groups(6 months)
- Reduction in End Systolic Volume(6 months compared to baseline)
- Difference in Heart Failure Symptoms(6 months)