coHOrte fraNcaise Des dEfibrillateurs Sous cuTanés
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Ventricular Arrhythmias
研究概览
简要总结
Implantable cardioverter-defibrillators have been proven to be effective in the prevention of sudden cardiac death in high-risk patients. However, it is well acknowledged that such a strategy could be optimised, especially through new technologies/devices. Data on the entirely sub-cutaneous implantable cardioverter defibrillator (S-ICD) published so far come from high-volume centers and/or selected populations. The HONEST Cohort -taking the opportunity of a unique scenario with a single manufacturer and remote monitoring system available- aims to collect retrospectively baseline information as well as follow-up of all patients implanted with an S-ICD in France since the first implant in October 13, 2012 until December 31, 2019. An extended prospective yearly follow-up will be carried out since January 1, 2020 until December 31, 2024.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who require S-ICD implantation (new or battery replacement)
排除标准
- •Refusal of consent
结局指标
主要结局
Ventricular Arrhythmias
时间窗: Through study completion, an average of 5 years
Rate of appropriate ICD therapies for ventricular tachycardia / fibrillation
Device-Related Complications
时间窗: Through study completion, an average of 5 years
Rate of complications related to ICD including inappropriate therapies, infection, lead or generator dysfunction
Overall and Specific Mortalities
时间窗: Through study completion, an average of 5 years
Overall mortality and causes of death
次要结局
- Early Device-Related Complications(3 months)
- Late Device-Related Complications(Through study completion, an average of 5 year)
- Stratified Analyses by Sex, Underlying Heart Disease(Through study completion, an average of 5 year)