NCT00267137已完成不适用
Study for Atrial Fibrillation Reduction (SAFARI)
Medtronic Cardiac Ablation Solutions34 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2002年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 540
- 试验地点
- 34
- 主要终点
- Safety/Efficacy
研究概览
简要总结
Atrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the heart, is the world's most common kind of irregular heart beat. People with AF experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness. Although AF can occur in otherwise healthy people for no apparent reason, it is sometimes associated with high blood pressure, heart disease or lung problems. The purpose of the SAFARI trial is to study the effectiveness of pacing algorithms in the upper chamber of the heart for patients who have both AF and bradycardia (slow heart beat).
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
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a slow heartbeat who are in need of dual chamber pacing (pacing in both the atrium and ventricle).
- •Subjects who have experienced at least two episodes of rapid heart beats three months prior to enrollment.
排除标准
- •Subjects who have a history of permanent (chronic) or persistent (non self-terminating) atrial fibrillation.
- •Subjects with atrial fibrillation due to reversible cause, (e.g. thyroid disease, pericarditis, post-surgery, alcohol abuse).
- •Subjects with a history of one or more cardioversions (changing an abnormal heart rhythm into a normal one by either using medication or by the application of an electric shock) six months prior to enrollment.
结局指标
主要结局
Safety/Efficacy
次要结局
- Various
研究者
研究点 (34)
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