A Single Centre, Randomized, Single Blinded Trial of Wide Area Circumferential Ablation With Pulmonary Vein Isolation Compared to a Multipolar, Circular Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording
研究概览
简要总结
Atrial fibrillation (AF) is a chaotic heart rhythm of the top chambers of the heart. AF occurs in up to 10% of the population over the age of 60. It is associated with tiredness, impaired functional capacity and is the cause of up to 10% of strokes.
Ablation is a procedure performed with small tubes (catheters) that are introduced through the top of the leg. Burns are made inside of the heart to treat AF. This procedure has been shown to cure 90% of patients with intermittent (paroxysmal) AF.
The investigators currently use either one of two different catheters to create these burns inside the heart. The investigators do not know which is the best catheter to use in patients with paroxysmal atrial fibrillation.
The investigators study will randomly allocate patients to have their ablation performed by either one of the catheters to give a fair comparison between the two. The investigators objective is to study the differences between these two catheters.
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 paroxysmal AF with a planned ablation procedure
排除标准
- •Prior AF ablation
- •LA size greater than 60mm
- •Mechanical prosthetic MVR
- •Hypertrophic cardiomyopathy
结局指标
主要结局
Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording
时间窗: 1 year
Procedural time for pulmonary vein isolation
时间窗: Index procedure
次要结局
- All procedural complications(Index)
- Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure(6 months)
- Quality of life questionnaire(6 months and 1 year)
研究者
Pier Lambiase
Chief Investigator
University College London Hospitals