Utility of Analyzing Atrial Signal Electrograms in Patients with Atrial Fibrillation Using Next-Generation Ensite X Software: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Single-procedure freedom from AF
研究概览
简要总结
A single-center clinical trial on the analysis of intracardiac atrial electrogram mapping before and after ablation with the HD Grid Mapping Catheter and Ensite X Software, as a prospective study.
详细描述
This study was designed to determine the efficacy of substrate ablation using HD Grid Mapping Catheter could collected more AF electrogram and facilitate the mapping resolution and driver identification in AF patients who required substrate modification. This study is a prospective, single-center in which patients with AF who will receive catheter ablation.
The priority of substrate modification would be determined by the mapping with the HD Grid mapping catheter. The end-point of ablation is non-inducible of AF or AFL. The procedure time, fluoroscopic time, procedural termination rate, and recurrence of atrial arrhythmia would be collected. If the flutter or the non-PV triggers were inducible, isthmus ablation and the non-PV trigger ablation will be performed accordingly.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patents 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 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)
- •Patients with age less than 20 years old or greater than 80 years old regardless of gender.
结局指标
主要结局
Single-procedure freedom from AF
时间窗: From the catheter ablation date to 12 months
The study's primary endpoint was single-procedure freedom from AF after a blanking period based on a single procedure. After discharge, the patients were followed up (two weeks after the catheter ablation, then every 3 months) at our cardiology clinic or with the referring physician. During each follow-up, 24-hour Holter monitoring, or cardiac event recording was performed for a week. A 7-day holter will be performed in the 6th and 12th months. Recurrence was defined as any atrial arrhythmia recurrence, including AF and atrial tachycardia, and was defined as an episode lasting \>1 minute and confirmed by ECGs months after the ablation.
次要结局
- Non-inducibility of AF or AFL(During catheter ablation procedure)
- Any recurrence of all atrial arrhythmias after the first procedure(In the 6th and 12th months after catheter ablation.)
- Safety(From the catheter ablation date to 12 months follow-up)
研究者
Chin-Yu Lin
Taipei Veterans General Hospital, Department of Heart Rhythm Center and Cardiovascular Center. Associate Professor, School of Medicine, National Yang-Ming Chiao Tung University.
Taipei Veterans General Hospital, Taiwan