NCT07360158招募中不适用
Post-market Study for the CorSky Family of ICDs
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 151
- 试验地点
- 7
- 主要终点
- CorSky-related SADE-d free rate at 6 months
研究概览
简要总结
The CorSky family is BIOTRONIK´s new generation of ICDs. They are the successor devices of the current Acticor/Rivacor family and inherit all iShock/iShock_BC (Ilivia Neo, Intica Neo) implant and programmer software features.
The new features of CorSky Family are either true novel BIOTRONIK ICD features or mainly driven by unification with the Amvia pacemaker family (Amvia Edge, -Sky).
The goal of the study is to confirm the safety and performance of the CorSky Family of ICDs and CRT-Ds.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（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 guidelines
- •Planned for de novo implantation of an ICD/CRT-D, or upgrade/exchange from existing ICD/CRT-D or pacemaker
- •Ability to understand the nature of the study.
- •Ability and willingness to perform all on-site follow-up visits at the study site.
- •Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring® concept.
排除标准
- •For VR-T DX and CRT-DX: Permanent atrial tachyarrhythmia
- •For VR-T DX and CRT-DX: Patients requiring atrial pacing
- •Planned for His-Bundle-Pacing
- •Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
- •Pregnant or breast feeding.
- •Age less than 18 years.
- •Participation in an interventional clinical investigation in parallel to this study. ,
- •Life-expectancy less than 12 months.
结局指标
主要结局
CorSky-related SADE-d free rate at 6 months
时间窗: 6 months
CorSky-related SADE-d free rate at 6 months
次要结局
未报告次要终点
研究者
研究点 (7)
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