World-wide Survey on the Incidence, Diagnosis and Prognosis of Atrio-oesophageal Fistula Following Percutaneous Catheter Ablation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of AOF following percutaneous catheter ablation
研究概览
简要总结
Pulmonary vein isolation emerged as an effective and safe strategy to treat atrial fibrillation patients. Atrio-oesophageal fistula (AOF) represents a rare but devastating complication of AF ablation procedure. This complication (0.016-0.07%) requires an international effort to allow for better understanding of the factors contributing to its occurrence and the best management strategies. A worldwide, retrospective, multicenter registry focusing on the incidence, diagnosis and management of this complication.
详细描述
Data about the incidence, optimal management and outcome of AOF is sparse. The largest national and international surveys report on less than 50 AOF. The latest worldwide survey was conducted in 2015 and managed to include 31 patients who developed AOF after atrial fibrillation ablation procedure. In the meanwhile, the total number of AF ablation procedures increased significantly. Additionally, AF ablation technology changes significantly with e.g. increasing numbers of cryoballoon ablation and contact force guided radiofrequency ablation.
The study is designed as a worldwide, multi-centre, anonymised registry study to evaluate the incidence, optimal management and outcome of this AOF. More than 50 patients with AOF following percutaneous catheter ablation will be included in the register.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atrio-oesophageal fistula after Ablation
- •Indication for AF ablation as per current guidelines
- •Performing the ablation at an ablation centre
排除标准
- •No Atrio-oesophageal fistula after Ablation
结局指标
主要结局
Incidence of AOF following percutaneous catheter ablation
时间窗: 5 year
1. Evaluating the Incidence of atrio-oesophageal fistula after percutaneous catheter ablation in patients with atrial fibrillation, as well as the more detailed analysis of the incidence of AOF after PVI with Cryo Balloon or RF Contact Force
次要结局
- Diagnosis and management of AOF(5 year)
- Mortality rate(5 year)
研究者
Prof. Roland Richard Tilz
Prof. Dr. med. Roland Richard Tilz
University of Luebeck