NCT00599976已完成不适用
Randomized Controlled Trial of Pulmonary Vein Antrum Isolation vs. AV Node Ablation With Bi-Ventricular Pacing for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure (PABA CHF)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 主要终点
- composite of EF, 6-minute walk distance and MLWHF score
研究概览
简要总结
For patients with atrial fibrillation and heart failure, current treatment can include AV nodal ablation with biventricular pacing. Pulmonary vein isolation (PVI) is a new procedure for this patient population which attempts to restore sinus rhythm. This trial is a randomized controlled trial of AVN ablation with biventricular pacing versus PVI for atrial fibrillation patients with congestive heart failure.
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
- •Patients with symptomatic atrial fibrillation with NYHA II-III symptoms despite the use of anti-arrhythmic medications.
- •Ejection fraction was required to be ≤ 40%.
- •Patients were required to be on a heart failure regimen that included beta-blockers and ace-inhibitors or angiotensin receptor blockers for all patients and spironolactone for NYHA III patients.
- •Patients were required to complete a 6-minute walk test and to be ≥ 18 years of age.
排除标准
- •Reversible causes of AF and heart failure (HF) such as pericarditis, hyperthyroidism, valvular heart disease and tachycardia-induced cardiomyopathy.
- •Post-operative AF, previous MAZE or MAZE-like surgery, previous left atrial instrumentation
- •Life expectancy ≤ 2 years
- •Likely cardiac transplant within the next 12 months
- •Contraindication to anti-arrhythmic medications and/or anticoagulation
- •Severe pulmonary disease
- •Documented intra-atrial thrombus
- •Tumor or other abnormalities which preclude catheter introduction
- •Cardiac surgery, MI or PCI within the past three months.
结局指标
主要结局
composite of EF, 6-minute walk distance and MLWHF score
时间窗: 6 months
次要结局
- freedom from AF and left atrial size(6 months)
研究者
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