NCT05621187已完成不适用
BIO|MASTER.Pamira Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 24
- 主要终点
- Pamira lead related SADE-d free rate at 6 months after implantation
研究概览
简要总结
Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims by
- demonstrating clinical safety
- evaluating performance based on sensing and pacing assessment
- collecting additional data of interest to assess other aspects such as the handling and usability
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 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 a BIOTRONIK ICD or CRT-D in combination with Pamira
- •Ability to understand the nature of the study and 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 the BIOTRONIK Home Monitoring® concept
排除标准
- •Mechanical tricuspid valve prosthesis or a severe tricuspid valve disease
- •Known Dexamethasone acetate intolerance
- •Cardiac surgical post-implantation procedure planned within 12 months (including interventional procedures like ablation, valve replacement, heart transplant etc.)
- •Less than 18 years old
- •Pregnant or breast feeding
- •Participating in another interventional clinical investigation
- •Life-expectancy less than 12 months
结局指标
主要结局
Pamira lead related SADE-d free rate at 6 months after implantation
时间窗: 6 months
次要结局
- 2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up(6 months, 12 months)
- 3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up(6 months, 12 months)
- 1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation(3 months, 12 months)
研究者
研究点 (24)
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