Is Ablation of All Inducible Atrial Tachycardias an Appropriate Endpoint During Redo Procedures After Initial Persistent AF Ablation? A Multi-center, Randomised, Single-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Freedom from any documented episode of AT or AF lasting longer than 30 seconds without AAD and occurring during the 1 year follow-up after the ATPAF ablation procedure.
研究概览
简要总结
In the treatment of symptomatic drug resistant persistent atrial fibrillation (Ps AF), catheter ablation has a class IIA indication. During the follow-up, a significant amount of patients (~50%) will experience atrial tachycardias (AT) recurrence. The endpoint of AT ablation during the second procedure has not been validated. At present, several strategies are considered as good clinical practice.
Main objective: To evaluate if ablation of all inducible AT post AF ablation (ATPAFA) offers as substantial benefit in comparison with ablation of the clinical ATPAF only during a redo procedure post initial persistent AF ablation.
Secondary objectives:
To evaluate the prognosis of non-inducibility during a redo procedure for ATPAFA
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
- •Male or Female Adults (≥18 years old)
- •Patients with stable ATPAF at least two months after the first AF ablation procedure.
- •Consent signed by the patient after reading the information leaflet
排除标准
- •Mental or physical inability to take part in the study
- •Spontaneous AF in the EP lab
- •Presence of any pulmonary vein stents
- •Presence of any pre-existing pulmonary vein stenosis
- •Presence of any cardiac valve prosthesis
- •Clinically significant mitral valve regurgitation or stenosis
- •Myocardial infarction, PCI / PTCA or coronary artery stenting within the last 3 months
- •Unstable angina
- •Any cardiac surgery within the last 3 months
- •NYHA class III or IV congestive heart failure
- •Uncontrolled hyperthyroidism
结局指标
主要结局
Freedom from any documented episode of AT or AF lasting longer than 30 seconds without AAD and occurring during the 1 year follow-up after the ATPAF ablation procedure.
时间窗: During 12 months follow-up
There will be a 1-months blanking period after ATPAF ablation. A repeated left atrial ablation at any time (even during the blanking period) will be considered as a recurrence.
次要结局
- Incidence of procedure related complications(During 12 months follow-up)
- Correlation of the AT mechanism during the redo procedure with the AT Mechanism during the index procedure(At repeat procedure(s) during the 12 months follow-up)
- Incidence of repeat procedures(During 12 months follow-up)
- The number of non-inducible ATPAFA during a redo procedure(At repeat procedure(s) during the 12 months follow-up)
- Procedure time(Baseline)
- Fluoroscopy duration(Baseline)
研究者
Sebastien Knecht
Professor Doctor
AZ Sint-Jan AV