NCT00589992Unknown不适用
Atrial Fibrillation Mechanism Analysis Through Ibutilide Administration During Pulmonary Vein Ablation.
Ball Memorial Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To discern the basic mechanism of Afib by studying its response to Ibutilide administration.
研究概览
简要总结
To test the hypothesis that localized functional reentry maintains Afib in humans, ibutilide will be administered intravenously in patients undergoing an Afib ablation. The hypothesis of this study is that ibutilide will decrease the high frequency signals observed in Afib suggesting the presence of micro reentrant circuits as the basic mechanism of Afib, especially for the paroxysmal Afib group. The potential difference in response to the ibutilide in patients with paroxysmal versus persistent Afib may show the difference in the underlying mechanism of Afib between these two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •patients to be scheduled for atrial fibrillation radio frequency ablation
- •paroxysmal, permanent symptomatic atrial fibrillation refractory to conventional treatment
- •symptomatic atrial fibrillation that do not want or desire to take medication or undergo cardioversion
- •patients on antiarrhythmics that can be discontinued 5 half lifes prior to the procedure except for Amiodarone
排除标准
- •patients with recent major hemorrhage (within 6 months)
- •patients with a coagulopathy
- •patients who are pregnant or breast feeding
- •patients with acute congestive heart failure
- •patients with hypokalemia or hyperkalemia
- •patients with a prolonged QTc > 440mms
- •patients with polymorphic ventricular tachycardia secondary to antiarrhythmic class III and class I
- •patients with left ventricular dysfunction < 40%
- •patients with a history of recent MI (< 1 month)
- •patients with a history of an angioplasty of < 1 month
- •patients with a history of coronary artery bypass grafting surgery of < 3 months.
- •patients with a history of chronic renal failure or a creatinine clearance of < 30ml/m
- •patients with a history of stroke of < 6 months
结局指标
主要结局
To discern the basic mechanism of Afib by studying its response to Ibutilide administration.
时间窗: one year
次要结局
- To improve the current results of pulmonary vein isolation by performing a procedure guided by ablation of high dominant frequency areas.(One year)
- To compare the ibutilide response in patients with paroxysmal versus permanent Afib(one year)
- To study the subgroup of patients that converted to sinus rhythm in order to identify various factors that may have increased their susceptibility to ibutilide.(one year)
研究者
研究点 (2)
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