NCT00950092终止不适用
Numeris-AF Tethered Coagulation System With VisiTrax Indicated For Treatment of Persistent and Longstanding Persistent Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- The primary effectiveness endpoint will be assessed as number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) through 9 months post procedure.
研究概览
简要总结
This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and longstanding persistent AF during concomitant cardiac surgery.
详细描述
The purpose of this study is to determine the safety and efficacy of the Numeris-AF Tethered Coagulation System with VisiTrax when used to treat persistent and longstanding persistent Atrial Fibrillation(AF)during concomitant cardiac surgery.
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 =< 6.0 cm
- •Documented persistent or longstanding persistent AF
- •History of AF =< 10 years
- •Scheduled for a concomitant cardiac procedure
- •Coronary bypass surgery (CABG)
- •Mitral valve repair/replacement
- •Aortic valve replacement
- •ASD repair
- •Tricuspid valve repair/replacement
- •Any combination of the above procedures
- •Provided written informed consent
排除标准
- •Left atrial size > 6.0 cm (pre-op TTE - parasternal 4 chamber view)
- •History of AF > 10 years
- •Left ventricular ejection fraction < 30%
- •Pregnant or planning to become pregnant during study
- •Co-morbid medical conditions that limit one year life expectancy
- •History of coagulopathy
- •Patients who are contraindicated for anticoagulants(heparin, warfarin etc.)
- •Previous cardiac surgery
- •History of pericarditis
- •Previous cerebrovascular accident (CVA)
- •Patients who have active infection or sepsis
- •Patients who have uncorrected reversible cause(s) of AF such as hyperthyroidism and electrolyte imbalance
- •Patients who are being treated for ventricular arrhythmias
- •Patients who have had a previous catheter ablation for AF (does not include ablation for Aflutter)
- •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
The primary effectiveness endpoint will be assessed as number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) through 9 months post procedure.
时间窗: 9 months
次要结局
- Secondary effectiveness endpoint: Proportion of subjects free from AF regardless of their Class I and III AADs status through 9 months post procedure.(9 months)
- Secondary effectiveness endpoint: Proportion of subjects free of AF/ AFL / AT and off all Class I and Class III AADs.(9 months)
研究者
研究点 (4)
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