NCT00519194终止不适用
CONcomitant eValuation of Epicor Left atRial Therapy for AF
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 112
- 试验地点
- 30
- 主要终点
- Freedom From Atrial Fibrillation in the Absence of Any AF Therapies
研究概览
简要总结
The purpose of this study is to test the safety and efficacy of the Epicor LP Cardiac Ablation System for treating permanent atrial fibrillation during concomitant open chest and/or open heart surgery for one of more of the following procedures: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, coronary artery bypass surgery or patent foramen ovale (PFO closure).
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
- •18-80 years old
- •Permanent AF defined as continuous AF lasting > one year OR non self-terminating AF lasting > seven days but no more than one year with at least one failed DC cardioversion
- •Have a concomitant indication for open chest and/or open heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, patent foramen ovale (PFO) closure or coronary artery bypass surgery
- •Be able to take anticoagulation therapy
- •Be able to fulfill study requirements
- •Be able to sign study-specific informed consent
排除标准
- •Presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy
- •Prior cardiac surgery
- •Presence of active endocarditis, local or system infection
- •Presence of advanced heart failure (NYHA class > II, & LVEF < 20%)
- •Intraaortic balloon pump, IV inotropes or vasoactive agents within 30 days
- •Emergent cardiac surgery due to acute MI or acute mitral regurgitation
- •Life expectancy < 1 year
- •Major or progressive non-cardiac disease
- •Presence of left atrial thrombi
- •Left atrial diameter > 6.0 cm
- •Any condition that prevents investigator from safely performing procedure
- •Positive urine or serum pregnancy test
- •Prior left atrial ablation
- •Currently participating in another clinical research study
研究组 & 干预措施
Epicor Cardiac Ablation
Experimental
干预措施: Epicor LP Cardiac Ablation System (Device)
Epicor Cardiac Ablation
Experimental
干预措施: Surgical ablation of permanent AF (Procedure)
结局指标
主要结局
Freedom From Atrial Fibrillation in the Absence of Any AF Therapies
时间窗: 6 months
Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.
次要结局
未报告次要终点
研究者
研究点 (30)
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