NCT01444573Unknown3 期
Rate Ventricular Control Therapy by Implantable Continuous Monitor in Patients With Permanent Atrial Fibrillation
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2011年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Hospitalization for all cardio-vascular events
研究概览
简要总结
The investigators hypothesized that very lenient rate control is not inferior to strict or lenient rate control assessed by implantable continuous ECG monitor for preventing cardiovascular hospitalization and mortality in patients with long-standing persistent or 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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Long-standing persistent or permanent atrial fibrillation
- •Mean resting heart rate > 80 beats per minute with or without rate control medication
- •Age < 70 years old
- •Constant use of anticoagulation therapy
排除标准
- •Paroxysmal or persistent atrial fibrillation
- •Non-stable heart failure or > III NYHA FC
- •Indications for IPG/CRT/ICD
- •Thyroid dysfunction
- •Inability to walk or bike.
结局指标
主要结局
Hospitalization for all cardio-vascular events
时间窗: 12 months
次要结局
- All-cause death(12 months)
- stroke(12 months)
- life-threatening arrhythmic and drugs adverse events(12 months)
研究者
研究点 (2)
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