Eluna Family / Sentus BP Master Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 17
- 主要终点
- Eluna pacemaker family: Serious Adverse Device Effect (SADE) - free rate
研究概览
简要总结
The Eluna Family / Sentus BP Master Study is designed to confirm the safety of the new Eluna pacemaker family and the Sentus BP (bipolar) left ventricular lead.
Furthermore the new wandless RF telemetry function "SafeSync" and the handling of the Sentus lead during implantation will be assessed.
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
- •Patient is willing to participate in the study and provided written informed consent
- •Patient meets standard indication for pacemaker or CRT-P or CRT-D therapy
- •Patient accepts Home Monitoring® concept
- •Patient has legal capacity and ability to consent
排除标准
- •Patient with any contraindication to pacemaker and CRT-P and CRT-D therapy
- •Patient under the age of 18
- •Pregnant or breast-feeding women
- •Cardiac surgery planned within the next 6 months
- •Life expectancy less than 12 months
- •Participation in another cardiac clinical investigation with active treatment arm
- •Group B only: Currently implanted with an endocardial or epicardial LV lead or had prior attempt to place a LV lead (for CRT implants only)
结局指标
主要结局
Eluna pacemaker family: Serious Adverse Device Effect (SADE) - free rate
时间窗: 6 months
The safety of the Eluna pacemaker family will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the pacemaker will be the basis for endpoint calculation of the SADE-free rate.
Sentus BP lead: Serious Adverse Device Effect (SADE) - free rate
时间窗: 3 months
The safety of the Sentus BP left ventricular lead will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the Sentus BP lead will be the basis for endpoint calculation of the SADE free rate.
次要结局
未报告次要终点