NCT05023590Unknown不适用
Monocentric, Randomized, Prospective Study to Compare Endocardiac Radio Frequency Ablation and Cryo Ablation of the Left Atrium During an Open Chest Mitral Valve Intervention
Herz- und Gefaesszentrum Bad Bevensen2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年2月22日最近更新:
适应症
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
- number of patients with stabil sinus rhythm 6 month after ablation
研究概览
简要总结
Monocentric, prospective, randomized trial of cardiac surgical arrhythmia using endocardial radiofrequency atrial ablation compared with a cryo ablation system in the setting of cardiac surgery.
详细描述
Regular, rhythmic monitoring (24-hour Holter ECG, 5 and 28 days, 3 and 6 months po) of patients after cardiac surgery on the mitral valve with atrial ablation for paroxysmal, persistent, and permanent atrial fibrillation with regard to the presence or stability of sinus rhythm.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years
- •Present, written informed consent from the patient
- •paroxysmal, persistent, or permanent atrial fibrillation not longer than 10 years according to guidelines (ACC, AHA, ESC)
- •planned cardiac surgery on the mitral valve
- •ECHO parameters : LA size a.p. ≤ 55mm
排除标准
- •permanent atrial fibrillation longer than 10 years
- •ECHO parameters : LA size a.p. > 55mm
- •pregnancy
- •life expectancy < 12 months
- •lack of cognitive or mental capacity to participate in the study
- •Patients who are to be included in another clinical (interventional) study at the same time or who are already participating in such a study
结局指标
主要结局
number of patients with stabil sinus rhythm 6 month after ablation
时间窗: 6 month after index surgery / ablation
number of patients with stabil sinus rhythm 6 month after ablation
次要结局
未报告次要终点
研究者
研究点 (2)
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