NCT02014675已完成不适用
SD01 Registry (SD01 ICD Lead)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 10
- 主要终点
- SADE-free rate
研究概览
简要总结
This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.
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
- •Meet a standard indication for ICD/CRT-D therapy
- •First ICD/CRT-D implantation or upgrade from pacemaker
- •Signed informed consent form
- •Willing to participate for the whole duration of the registry
- •Patient accepts Home Monitoring concept and is able to activate and use the Cardiomessenger
- •Patient has legal capacity and ability to consent
排除标准
- •Meet a standard contraindication for an ICD/CRT-D therapy
- •Age <18 years
- •Pregnant or breast-feeding women
- •Cardiac surgery planned within the next six months
- •Enrollment in another cardiac clinical investigation with active treatment arm
- •Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
- •Dexamethasone acetate intolerance
结局指标
主要结局
SADE-free rate
时间窗: 10 years
次要结局
未报告次要终点
研究者
研究点 (10)
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