Registry of Patients Underwent Cardiac Implanted Electronic Device Implantation at Monaldi Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- CIEDs Infection
研究概览
简要总结
The study is a prospective registry. Consecutive patients with indications of implant / replacement or upgrade of pacemaker (PM), implantable cardioverter defibrillator (ICD), Implanted loop recorder (ILR) will be enrolled.
The primary objective of the study is to describe the clinical events during a long-term follow-up of non-selected population of patients implanted with an PM, ICD or ILR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients underwent PM/ICD/ILR implantation
- •Patient is willing and able to sign an authorization to use and disclose health information or an Informed Consent
- •Patient must be able to attend all required follow-up visits at the study center for at least 12 months
排除标准
- •No informed consent
- •Patient is participating in another clinical study that may have an impact on the study endpoint
- •Exclusion Criteria:
- •No informed consent
结局指标
主要结局
CIEDs Infection
时间窗: through study completion, an average of 1 year
The number of patecipants with infections following implantation of cardiac implantable electronic devices
Inappropriate ICD Therapies
时间窗: through study completion, an average of 1 year
The number of partecipants with at least one episode of antitachycardia pacing therapy or shock delivered by ICD for device detected sopraventricular arrhythmias.
Appropriate ICD Therapies Antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmia
时间窗: through study completion, an average of 1 year
The number of partecipants with a least one episode of antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmias.
次要结局
未报告次要终点
研究者
Vincenzo Russo
Principal Investigator
University of Campania "Luigi Vanvitelli"