Phase 4. Study of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation.
研究概览
简要总结
The aim of the present study is to compare the response to cardiac resynchronization therapy (CRT) in patients with chronic advanced heart failure and permanent atrial fibrillation (AF) depending on atrio ventricular junction (AVJ) is ablated or not.
详细描述
Cardiac resynchronization therapy (CRT) improves the functional capacity and the quality of life and reduces the mortality of patients with dilated cardiomyopathy, low ejection fraction and wide QRS.
Only 2% of patients included in CRT randomized trials were in AF.
To obtain a good response to CRT, percentage >90% of ventricular pacing must be obtained.
Based on observational studies, current guidelines of CRT recommend the atrio ventricular junction (AVJ) ablation in those patients with permanent atrial fibrillation.
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
- Single (Outcomes Assessor)
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
- •Dilated cardiomyopathy (LVEDD >56 mm)
- •wide QRS (> 120 msec)
- •NYHA III-IV
- •Permanent AF
排除标准
- 未提供
研究组 & 干预措施
Atrioventricular junction ablation
Atrioventricular junction ablation by using radiofrequency energy.
干预措施: Atrio ventricular junction ablation with radio-frequency (Procedure)
Drug control of ventricular rate
Drug control of ventricular rate.
干预措施: Beta blocker/digoxine/amiodarone (Drug)
结局指标
主要结局
Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation.
时间窗: 1-year follow-up
Comparison of echocardiographic responders in patients with permanent atrial fibrillation submitted to cardiac resynchronization therapy depending on whether the atrio-ventricular junction is ablated or not. Echocardiographic response was defined as left ventricular end-systolic volume reduction \>10%.
次要结局
- Clinical response to Cardiac resynchronization therapy.(1-year follow-up)
研究者
Josep Lluis Mont Girbau
Head of the Arrhythmia Unit
Hospital Clinic of Barcelona