跳至主要内容
临床试验/NCT04767516
NCT04767516已完成不适用

Multicenter Registry of Subcutaneous ICD Patients

Universitätsklinikum Köln1 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,300
试验地点
1
主要终点
Lead Failure

研究概览

简要总结

This multicenter registry aims to collect data regarding S-ICD longevity, and battery and lead failure rates. Only clinically collected data is gathered in this registry.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • S/P S-ICD Implantation

排除标准

  • 未提供

结局指标

主要结局

Lead Failure

时间窗: from baseline to incidence of lead failure,through study completion, an average of 5 year

Incidence of S-ICD lead failure. Assessed by medical records and device interrogation.

Generator Explantation

时间窗: from baseline to incidence of explantation through study completion, an average of 5 year

Incidence of S-ICD generator explantation, due to battery depletion, infection or system upgrade. Assessed by medical records and device interrogation.

次要结局

  • Battery Longevity(from baseline to incidence of battery depletion through study completion, an average of 5 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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