NCT00637754已完成不适用
Safety of Sports for Patients With Implantable Cardioverter-Defibrillators: A Multi-Center Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 54
- 主要终点
- Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock.
研究概览
简要总结
The registry will obtain information to determine the safety of sports participation for patients with defibrillators (ICDs).
详细描述
Patients who are participating in sports who have defibrillators will be invited to participate in a prospective registry to determine the rate of adverse events occurring during sporting activities. Patients will be followed for four years and adverse events quantified. Yale is the coordinating center for this multicenter registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals between the ages of 10 and 60
- •has a defibrillator
- •plays a competitive/organized sport more vigorous than golf or bowling or participates in a dangerous sport
排除标准
- •children under 10 years (as they engage in primarily recreational sports)
- •individuals over the age of 60 years (maintain a homogenous population)
- •inability to give informed consent
结局指标
主要结局
Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock.
时间窗: four years
次要结局
- System malfunction and incidence of ventricular arrhythmias (VA) requiring multiple shocks for termination(four years.)
研究者
Rachel Lampert
Principal Investigator
Yale University
研究点 (54)
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