NCT02243696终止不适用
Protego DF4 Post Approval Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,694
- 主要终点
- Percentage of Subjects With No Protego DF4 Lead Adverse Event
研究概览
简要总结
The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Implanted within the last 30 days or candidate for implantation of a BIOTRONIK ICD or CRT-D DF4 compatible system along with the Protego DF4 lead
- •Meets ICD or CRT-D system implant recommendations as defined in guidelines published by relevant professional societies
- •Able to understand the nature of the registry and provide informed consent
- •Available for follow-up visits on a regular basis at the investigational site for the expected 5 years of follow-up
- •Age greater than or equal to 18 years
排除标准
- •Enrolled in any investigational cardiac device trial
- •Planned cardiac surgical procedures or interventional measures within the next 6 months
- •Expected to receive heart transplantation or ventricular assist device within 1 year
- •Life expectancy of less than 1 year
- •Presence of another life-threatening, underlying illness separate from their cardiac disorder
- •Patients reporting pregnancy at the time of enrollment
结局指标
主要结局
Percentage of Subjects With No Protego DF4 Lead Adverse Event
时间窗: Up to 4.5 years
Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
时间窗: Up to 4.5 years
Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.
次要结局
- Protego DF4 Lead Pacing Threshold Measurement(Up to 4.5 years)
- Protego DF4 Lead Sensing(Up to 4.5 years)
- Protego DF4 Lead Shock Impedance(Up to 4.5 years)
- Protego DF4 Lead Pacing Impedance(Up to 4.5 years)
- Percentage of Subjects With no Adverse Events Excluded From Primary Objectives(Up to 4.5 years)
研究者
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