A Randomized Controlled Study on the Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation
研究概览
简要总结
Atrial fibrillation (AF) has been the most frequently occurring, sustained arrhythmia, which causes significant morbidity and mortality. AF may not always be a totally random process. It can be maintained by stable and rapid reentrant circuits resulting in fibrillary conduction throughout the atria. During mapping of AF, difficulty is frequently encountered during the identification of culprit sites and an analysis of the wave propagation particularly when the electrogram signals demonstrate wide temporal and spatial disparities. Catheter ablation targeting regions with fractionated potentials or high frequencies during AF, has been previously proposed as a treatment strategy. However, the benefit of adjunctive CFAE (complex fractionated atrial electrogram) ablation or linear ablation after successful PVI (pulmonary vein isolation) was controversial based on the recent data from the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II (STAR AF II) trial. Therefore, the optimal ablation strategy for persistent AF remains undetermined and an alternative approach has to be explored.
详细描述
In this prospective trial, investigators will investigate the long-term efficacy of catheter ablation of non-paroxysmal AF, based on selective atrial substrate modification (e.g. wavefrom periodicity analysis, similarity, plus phase mapping) (1). The control group would be PV isolation alone. The primary end point is long-term recurrence of atrial arrhythmias. The secondary end points composite procedural termination, the safety of the procedure, recurrence of multiple procedures, and change of atrial and ventricular function after catheter ablation.
The inclusion criteria, exclusion criteria, stepwise catheter ablation procedures (PVI and then substrate modification), and the follow-up procedure are the same as current treatment approaches in patients with non-paroxysmal AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who sign the informed consent forms, and allow to be followed.
- •Symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication.
- •Patients with persistent/permanent AF (sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion).
- •Patients with age equal or greater than 20 years old regardless of gender.
排除标准
- •The presence of a atrial or ventricular thrombus.
- •Patients who are allergic to or unsuitable for use with the contrast media.
- •Pregnant patients or patients who are unavailable to receive X-ray.
- •Patients with renal insufficiency.
- •Patients had autonomic nervous system disorder (e.g. respiratory apnea) or previous catheter ablation in the LA or MAZE procedure.
- •Patients who do not need atrial substrate modification (patients with non-paroxysmal AF respond to PVI in terms of procedural termination of AF).
- •Patients with age less than 20 years old or greater than 90 years old regardless of gender.
结局指标
主要结局
changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation
时间窗: Baseline and 3, 6, 9 and 12 months after catheter-based ablation of atrial fibrillation
A 24-hour Holter monitoring and/or ECG (7 days recordings) will be performed at 3, 6, 9, and 12 months post ablation and/or when the patients experience symptoms suggestive of a tachycardia after the ablation. Measurements: documentation of AF signal duration more than 30 seconds.
次要结局
- e/e'(after catheter ablation of atrial fibrillation 3, 6, 12 month)
- LVEF(after catheter ablation of atrial fibrillation 3, 6, 12 month)
- LAD(after catheter ablation of atrial fibrillation 3, 6, 12 month)