NCT03056222已完成不适用
CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
I-Med-Pro GmbH22 个研究点 分布在 4 个国家目标入组 360 人开始时间: 2017年4月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 22
- 主要终点
- Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs
研究概览
简要总结
The aim of the study is to compare the acute procedure and safety outcomes as well as long term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must not have undergone a previous ablation for the treatment of PAF
- •AF Type - Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) where PAF is defined as recurrent (two or more) episodes of AF that terminate spontaneously in less than seven days, usually less than 48 hours
排除标准
- •Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
- •Diagnosed with persistent atrial fibrillation defined as recurrent episodes lasting more than 7 and less than 365 days
- •More than 4 electrical cardioversions in the year prior to enrollment but not including cardioversions performed within 48 hours of arrhythmia onset
- •Documented left atrial thrombus on imaging
- •Cannot be removed from anti-arrhythmic drugs for other reasons than atrial fibrillation
- •New York Heart Association (NYHA) functional Class III or Class IV heart failure
- •Left ventricular ejection fraction < 30%
- •Left atrial size > 55 mm as measured in the parasternal antero-posterior view
- •Myocardial infarction within 60 days prior to enrolment
- •Woman of childbearing potential who is pregnant, lactating or not using adequate birth control
结局指标
主要结局
Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs
时间窗: 12 months post procedure
Recurrent AF is defined as any documented episode of AF lasting more than 30 seconds after a blanking period of 90 days post procedure
次要结局
- Incidence of peri-procedural complications(From procedure to 12 months post procedure)
- Acute procedure success(30 minutes post procedure)
- Procedure and fluoroscopy time(During procedure)
- Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs(12 months post procedure)
研究者
研究点 (22)
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