NCT01057485Unknown不适用
Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation
Eastbourne General Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To measure the two treatment effects on VO2 max over time by means of cardiopulmonary exercise testing.To measure the two treatment effects on 6-minute hall walk distance.Echocardiographic parameters
研究概览
简要总结
The purpose of the study is to assess combining AF ablation, with AV node ablation and pacemaker implantation for patients suffering with 'irregular heartbeats' or atrial fibrillation. The study will last 13 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
- Single (Participant)
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 drug refractory atrial fibrillation.
- •Patients who have had pacemaker implantation and AV node ablation with ongoing symptoms.
- •Patients will already be refractory to at least 2 rate or rhythm control drugs.
- •Patients must be over 18 years old.
- •Patients give informed consent form prior to participating in this study.
排除标准
- •Patient is suffering with unstable angina in last 1 week.
- •Patient has had a myocardial infarction within last 2 months.
- •Patient is expecting or has had major cardiac surgery within last 2 months.
- •Patient is participating in a conflicting study.
- •Patient is unable to perform exercise testing.
- •Patient is mentally incapacitated and cannot consent or comply with follow-up.
- •Patient has NYHA class III/ IV heart failure.
- •Patient has LVEF <35% not secondary to tachycardia.
- •Pregnancy.
- •Patient suffers with other cardiac rhythm disorders.
- •Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).
结局指标
主要结局
To measure the two treatment effects on VO2 max over time by means of cardiopulmonary exercise testing.To measure the two treatment effects on 6-minute hall walk distance.Echocardiographic parameters
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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