Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- AF free off all Class I and III Anti Arrhythmic Drugs (AADs).
研究概览
简要总结
This is a multi-center, prospective, open label, feasibility clinical study,evaluating the safety and efficacy of the combined ablation procedure for the treatment of symptomatic paroxysmal atrial fibrillation.
详细描述
The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure for the treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (AF) patients, using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster NaviStar® ThermoCool® Diagnostic/Ablation deflectable Tip Catheter in conjunction with the Carto Navigation System endocardially.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age > 18 years; < 80 years
- •Left atrium less than or equal to 6.5 cm (TTE)
- •Symptomatic paroxysmal AF
- •Provided written informed consent
- •Refractory to at least one AAD (class I, II, III or IV)
排除标准
- •Patients requiring concomitant surgery
- •Left ventricular ejection fraction < 30%
- •Pregnant or planning to become pregnant during study
- •Co-morbid medical conditions that limit one year life expectancy
- •Measured left ventricular wall thickness > 1.5 cm
- •History of coagulopathy
- •Previous cardiac surgery
- •Right ventricular outflow tract obstruction
- •History of pericarditis
- •Previous cerebrovascular accident (CVA), excluding fully resolved TIA
- •Patients who have severe chronic obstructive pulmonary disease (COPD)
- •Patients who have an active infection or sepsis
- •Patients who have uncorrected reversible cause(s) of AF
- •Patients who are contraindicated for anticoagulants
- •Patients who are being treated for arrhythmias other than AF
- •Patients who have had any previous AF or left atrial catheter ablation
- •Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment.
- •Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).
结局指标
主要结局
AF free off all Class I and III Anti Arrhythmic Drugs (AADs).
时间窗: 12 months
The primary efficacy data will be an evaluation of the number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) from 3 months through 12 months post procedure.
次要结局
- AF free regardless of the Class I and III AADs status(12 months)