NCT00180375已完成不适用
OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 636
- 试验地点
- 33
- 主要终点
- Time to first appropriate therapy
研究概览
简要总结
This study evaluates the date of the first appropriate and/or inappropriate therapy in patients implanted with a Guidant PRIZM or VITALITY defibrillator and is evaluating eventual predictive risk factors for appropriate/inappropriate therapies as well as the influence of the programmed parameters on these therapies.
详细描述
The registry measured the times to, and studied the determinants of, first appropriate (FAT) and inappropriate (FIT) therapy delivered by single, dual and triple chamber (CRT-D) ICD implanted for primary and secondary prevention indications.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for an ICD according to current guidelines, incl. prophylactic indication
排除标准
- •pregnant or at birth bearing age without contraception, participation in another clinical trial, short life expectancy, geographically unstable for a follow-up at the investigational center
结局指标
主要结局
Time to first appropriate therapy
时间窗: 2 year-follow-up
Time to first inappropriate therapy
时间窗: 2 year-follow-up
次要结局
- Influence of cardiopathy, EF, NYHA Class, Type of ventricular arrhythmia (MVT, PVT, VF), History of atrial and ventricular arrhythmias, medical treatment (betablockers and/or Amiodarone).(2 year-follow-up)
- Type of treatment ATP/shock(2 year-follow-up)
研究者
研究点 (33)
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