Strategies in Patients Undergoing Repeat AF Ablation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Primary efficacy endpoint
研究概览
简要总结
The aim of the proposed research project is to compare the efficacy of three different ablation strategies in patients with atrial fibrillation (AF) who are undergoing their first repeat catheter ablation for recurrent AF.
详细描述
Reconnection of the pulmonary veins (PV) is generally responsible for AF recurrence in most cases. However, in a growing subset of patients undergoing repeat ablation for recurrent AF, the PVs are chronically isolated and no other non-PV triggers of AF can be identified. The investigators have previously shown that empirically ablating at known common non-PV trigger sites for AF can improve arrhythmia free survival beyond PVI. The left atrial (LA) posterior wall is also increasingly being isolated in AF patients undergoing catheter ablation. However, long term arrhythmia free survival in AF patients undergoing LA posterior wall isolation is not consistently better than PVI alone.
The objective of this study therefore is to assess whether performing empiric ablation of common non-PV trigger sites or achieving LA posterior wall isolation can improve arrhythmia free survival in AF patients who are undergoing repeat AF ablation and in whom the PV remain chronically isolated and/or do not demonstrate AF. The investigators propose to do this as prospective, randomized three arm study.
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)
盲法说明
patients will be blinded to strategy used
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
- •All patients undergoing first redo AF ablation who have chronically isolated pulmonary veins and no non-PV triggers with provocation testing (randomized intra-procedure).
排除标准
- •Patients in whom ≥1 PVs have reconnected and AF triggers can be elicited from the reconnected PV.
- •Patients who demonstrated non-PV triggers for AF.
- •Patients who have experienced arrhythmia recurrence post ablation where the recurrent arrhythmia is other than atrial fibrillation or typical atrial flutter
- •Failure to obtain informed consent
- •Patients with a mechanical mitral valve
研究组 & 干预措施
CTI/AAD (control)
In all arms, patients are undergoing first redo AF ablation and the pulmonary veins are chronically isolated and no non-PV triggers elicited during provocation. Arm 1- Cavo-tricuspid isthmus (CTI) ablation with adjustment and/or optimization of antiarrhythmic drug regimen where possible (control arm)
干预措施: Ablation (Procedure)
Posterior wall isolation
In all arms, patients are undergoing first redo AF ablation and the pulmonary veins are chronically isolated and no non-PV triggers elicited during provocation. Arm 2-LA Posterior wall isolation by creation of a LA roof and floor line
干预措施: Ablation (Procedure)
Empiric Isolation of common trigger sites
In all arms, patients are undergoing first redo AF ablation and the pulmonary veins are chronically isolated and no non-PV triggers elicited during provocation. Arm 3-empiric ablation of common sites of non-PV triggers of AF in both the right and left atria.
干预措施: Ablation (Procedure)
结局指标
主要结局
Primary efficacy endpoint
时间窗: 1 year
Freedom from atrial arrhythmias off antiarrhythmic medications at 1 year after 1 repeat ablation procedure. Subjects are seen at 6 weeks, 6 months and 1 year post procedure with ECG at each visit and monitors at 6 months and one year to assess efficacy. Information regarding medications, health status, arrhythmia symptoms, and ECG and monitor results documented.
次要结局
- Secondary endpoint(1 year)