Iperia Family / Sentus QP Master Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 24
- 主要终点
- Iperia ICD family: SADE free rate
研究概览
简要总结
The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device system.
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 able to understand the nature of the study and provides written informed consent.
- •Patient meets a standard indication for CRT-D (Sentus QP group) or ICD therapy.
- •Patient is able and willing to complete the planned follow-up visits at the investigational site.
- •Patient accepts the Home Monitoring® concept.
- •Age is ≥ 18 years.
- •Sentus QP group only: Patient is a candidate for a new (de novo) implant or an upgrade from an existing ICD or pacemaker utilizing a BIOTRONIK Sentus QP lead
排除标准
- •Patient has a standard contraindication for CRT-D (Sentus QP group) or ICD therapy.
- •Sentus QP group only: Currently implanted with an endocardial or epicardial LV lead or had prior attempt to place a LV lead.
- •Sentus QP group only: Cardiac surgery procedure (coronary bypass graft, valve surgery, or ablation) that is planned to occur within 3 months after implantation.
- •Patient is expected to receive ventricular assist device or heart transplantation within the next 3 months.
- •Patient is pregnant or breastfeeding.
- •Life expectancy of less than 3 months
- •Participating in another cardiac clinical investigation with active treatment arm.
结局指标
主要结局
Iperia ICD family: SADE free rate
时间窗: 3 months
The safety of the Iperia ICD 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 QP LV lead: Serious Adverse Device Effect (SADE) free rate
时间窗: 3 months
The safety of the LV 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 LV lead will be the basis for endpoint calculation of the SADE-free rate.
次要结局
- LV pacing threshold(3 months)