Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Oesophageal complications after RF Ablation depending on using an oesophageal probe
研究概览
简要总结
The Trial will evaluate the influence of oesophageal probes in Radio frequency (RF)-ablation of atrial fibrillation regarding oesophageal ulcers after ablation.
详细描述
The Trial will evaluate the influence of oesophageal probes in RF-ablation of atrial fibrillation regarding oesophageal complications after ablation.
200 patients will be prospectively randomised into 2 groups. The conventional group will undergo RF-Ablation of atrial fibrillation using an oesophageal probe to measure the temperature during ablation.
In the other group will receive ablation using fixed energy levels (25 Watt) at the posterior left atrial (LA) Wall without an oesophageal probe , All patients will get a gastroscopy for evaluation of oesophageal complications the day after the procedure.
All patients will have a 6 months follow up (FU) in our clinic to be reevaluated for complications (primary endpoint) and rhythm stability. (secondary endpoint)
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 lead ECG with documented atrial fibrillation
- •Indication for RF ablation of atrial fibrillation according to the recent guidelines
- •Signed informed consent
- •Age 18-85 years
排除标准
- •Pregnancy or possible pregnancy without negative test within 48h prior to ablation
- •Intracardiac thrombus
- •Contraindication for oral anticoagulation
- •Conditions, that may complicate the positioning of the oesophageal probe
结局指标
主要结局
Oesophageal complications after RF Ablation depending on using an oesophageal probe
时间窗: Up to 6 months
Incidence of oesophageal mucosa alterations in gastroscopy
次要结局
- Rhythm stability after RF ablation of atrial fibrillation (AF)(6 Months)