Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- AF recurrence
研究概览
简要总结
Comparison of Two Strategies for Catheter Ablation of Atrial Fibrillation - a comparison of ablation guided by Cartomerge and NavX Fusion. 3D mapping systems are widely used in catheter ablation of AF. Integration of a previously acquired image of the left atrium into the electroanatomical (EA) map offers several potential advantages, including visualisation of the complex anatomy of the left atrium, reduction of fluoroscopy time and improved results . The two most widely used systems are Cartomerge (Biosense Webster, etc) and NavX Fusion (SJM, etc). Although both systems have been independently validated, their clinical utility has not previously been directly compared in a randomised trial
详细描述
Patients are randomised to either NavX Fusion or Cartomerge. They undergo a standard catheter ablation procedure and data is collected. Both systems are routinely used in our clinical practise. This is a comparison trial of 2 mapping technologies.
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
- •Be at least 18 years of age
- •Be undergoing their first planned procedure for electrophysiology mapping and ablation in the left atrium of AF
- •Be willing and able to sign the study specific informed consent
- •Have a negative pregnancy test for female subjects of child bearing potential
排除标准
- •Have a left ventricular ejection fraction (LVEF) of <40% as evaluated by pre-procedure TTE
- •Have any contraindication or allergy to routine procedural medications or catheter materials
- •Have any condition for which the investigator feels it is unsafe for the subject to undergo an invasive electrophysiology procedure (EP) catheterisation
- •Be currently participating in another clinical research study
- •Have any condition for which the subject's life expectancy is less than twelve months
结局指标
主要结局
AF recurrence
时间窗: 6 months
Documentation of symptomatic arrhythmia or arrhythmia on a 7 day holter monitor at six-month follow-up
次要结局
- Lesion distance from CT shell(At completion of catheter ablation procedure (distance at defined procedure endpoint) (between 0 - 6 hours after procedure start))
- Procedural time points(At start, during and end of inpatient catheter ablation procedure. (between 0 & 6 hours after start of ablation procedure))
研究者
Dr Richard Schilling
Professor of Cardiology and Cardiac Electrophysiology
Barts & The London NHS Trust