Experience From the Long-term Italian Subcutaneous Implantable Cardioverter Defibrillator Registry (ELISIR)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 18
- 主要终点
- Appropriate shocks
研究概览
简要总结
The purpose of this registry is to collect data on implant parameters, early, mid and long-term clinical effectiveness of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) therapies in order to better understand how to improve the clinical care of patients and effectiveness of S-ICD therapies.
详细描述
ISIR is an observational, multicentric registry designed to collect implant and follow-up data of consecutive patients implanted with Subcutaneous Implantable Cardioverter Defibrillator (S-ICD).
A number of about 10 enrolling centers is estimated with an overall number of 400 patients.
A minimal follow-up of 6 months is required before analyzing clinical outcomes. The data analysis will focus on implant outcomes and early, mid and long-term effectiveness of S-ICD therapies and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age >/= 18 years
- •Patients successfully implanted with S-ICD
- •Patients able to provide written informed consent or have informed consent as provided by a legal representative
排除标准
- 未提供
结局指标
主要结局
Appropriate shocks
时间窗: 2 years
Appropriate therapies delivered by the devices
Mortality
时间窗: 2 years
Overall or arrhythmic mortality
Inappropriate shocks
时间窗: 2 years
Inappropriate therapies delivered by the devices
次要结局
未报告次要终点
研究者
Giovanni B Forleo
Section head electrophysiology and cardiac pacing
Luigi Sacco University Hospital