Plexa ICD Lead Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 901
- 试验地点
- 28
- 主要终点
- Percentage of Subjects Free From Plexa Lead Related Adverse Events
研究概览
简要总结
The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD 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
- •Successfully implanted with a BIOTRONIK ICD or CRT-D compatible system along with the Plexa lead no more than 30 days prior to consent
- •Able to understand the nature of the registry and provide informed consent
- •Available for follow-up visits on a regular basis at the study site for the expected 5 years of follow-up
- •Accepts BIOTRONIK Home Monitoring® concept
- •Age greater than or equal to 18 years
排除标准
- •Enrolled in any investigational cardiac device trial
- •Enrolled in BIOTRONIK's QP ExCELs lead study
- •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
- •Patients reporting pregnancy at the time of enrollment
结局指标
主要结局
Percentage of Subjects Free From Plexa Lead Related Adverse Events
时间窗: Up to 2.5 years
Evaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also included except for lead dislodgement, high pacing threshold, failure to capture, or intermittent capture.
次要结局
- Pacing Threshold Measurements for the Plexa Lead Through Study Termination(Up to 2.5 years)
- Plexa Lead Safety-Individual Adverse Events(Up to 2.5 years)
- Shock Impedance for the Plexa Lead Through Study Termination(Up to 2.5 years)
- Percentage of Subjects Free From Protocol Defined Adverse Events(Up to 2.5 years)
- Sensing Measurements for the Plexa Lead Through Study Termination(Up to 2.5 years)
- Pacing Impedance Measurements for the Plexa Lead Through Study Termination(Up to 2.5 years)