NCT06018818已完成不适用
BIO|MASTER.Amvia: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 3
- 主要终点
- SADE-free rate at 6 months
研究概览
简要总结
The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in the setting of a post-market clinical follow-up study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 de novo, upgrade or replacement pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation
- •Ability to understand the nature of the study
- •Willingness to provide written informed consent
- •Ability and willingness to perform all 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
- •Planned for conduction system pacing
- •Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
- •Known pregnancy or breast feeding
- •Age less than 18 years
- •Participation in another interventional clinical investigation
- •Life-expectancy less than 12 months
结局指标
主要结局
SADE-free rate at 6 months
时间窗: 6 months
Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months
次要结局
- aATP-related ADEs and SADEs(12 months)
- SADE-free rate at 12 months(12 months)
- CRT AutoAdapt AV delay(12 months)
- Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator(12 months)
- Auto LV VectorOpt(12 months)
- Sensing performance of device-based measurements(12 months)
- CRT AutoAdapt performance(12 months)
- Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator(2 months)
- Pacing performance of device-based measurements(12 months)
研究者
研究点 (3)
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