Freedom From Atrial Arrhythmia in Atrial Fibrillation Patients After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Outcome of atrial fibrillation ablation after permanent pulmonary vein antrum isolation or proven pulmonary vein antrum plus left atrial posterior wall isolation
研究概览
简要总结
Objective: This prospective study aims to examine the outcome of atrial fibrillation (AF) ablation after permanent pulmonary vein antrum isolation or pulmonary vein antrum isolation plus left atrial posterior wall isolation is proven by a repeat procedure. The study will be conducted in patients with different types of AF: paroxysmal AF (PAF) and non-PAF (Persistent AF and Long Standing Persistent AF).
Hypothesis: In addition to permanent pulmonary vein antrum isolation, proven isolation of left atrial posterior wall is associated with more freedom from atrial arrhythmia at long-term follow-up after atrial fibrillation ablation, especially in non-PAF patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AF patient undergoing primary catheter ablation (first procedure)
- •Ability to give informed consent
排除标准
- •Previous ablation of AF
- •Bleeding disorder
- •Reversible causes of AF, such as hyperthyroidism and phaeochromocytoma
研究组 & 干预措施
Pulmonary vein antrum isolation (PVAI)
Pulmonary vein antrum isolation (PVAI)
干预措施: Pulmonary vein antrum isolation (PVAI) (Procedure)
PVAI plus left atrial posterior wall (LAPW) isolation
PVAI plus left atrial posterior wall (LAPW) isolation
干预措施: PVAI plus left atrial posterior wall (LAPW) isolation (Procedure)
结局指标
主要结局
Outcome of atrial fibrillation ablation after permanent pulmonary vein antrum isolation or proven pulmonary vein antrum plus left atrial posterior wall isolation
时间窗: 12 months after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven by a repeat procedure
"Procedure success" is defined as freedom from atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) off antiarrhythmic drug during follow-up after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven. "Procedure failure" is defined as atrial arrhythmia recurrence during follow-up after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven.
次要结局
- Long-term outcome of atrial fibrillation ablation after permanent pulmonary vein antrum isolation or proven pulmonary vein antrum plus left atrial posterior wall isolation(24 and 36 months after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven by a repeat procedure)
- Quality of life after atrial fibrillation ablation(Before atrial fibrillation ablation and 3, 6, 12 months after normal sinus rhythm is restored by successful ablation(s))
研究者
Andrea Natale
Executive Medical Director
Texas Cardiac Arrhythmia Research Foundation