BIO|MASTER.Ilivia Family / Plexa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 292
- 试验地点
- 25
- 主要终点
- Ilivia Family Related SADE-free Rate Through 3 Months
研究概览
简要总结
Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Standard indication for ICD or CRT-D therapy according to clinical practice
- •De novo implantation or upgrade/exchange (group A only) from existing ICD, CRT-D or pacemaker implant
- •Patient is able to understand the nature of the clinical investigation and provides written informed consent
- •Patient is able and willing to complete all routine study visits at the investigational site
- •Patient accepts Home Monitoring concept
- •Age ≥ 18 years
排除标准
- •Contraindication to ICD or CRT-D therapy, respectively
- •For CRT-D patients in group A only: physician not willing to activate MultiPole Pacing in the patient
- •Cardiac surgical procedure planned within 6 months after implantation (including also interventional procedures like ablation, valve replacement etc.). Procedures to occur during or prior to implantation are not exclusionary.
- •Expected to receive heart transplant or ventricular assist device within 6 months
- •Life expectancy less than 6 months
- •Participation in any other interventional clinical investigation
- •Pregnant or breastfeeding at time of enrollment
研究组 & 干预措施
Ilivia ICD Family
Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting
干预措施: Ilivia ICD Family (Device)
Plexa ICD lead
Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting
干预措施: Plexa ICD lead (Device)
Ilivia ICD and Plexa lead
Implant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting
干预措施: Ilivia ICD Family (Device)
Ilivia ICD and Plexa lead
Implant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting
干预措施: Plexa ICD lead (Device)
结局指标
主要结局
Ilivia Family Related SADE-free Rate Through 3 Months
时间窗: 3 months
This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device
Plexa Related SADE-free Rate Through 6 Months
时间窗: 6 months
This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the "Plexa" lead
次要结局
- Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up(3 months)
- Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up(3 months)
- Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up(6 months)