Japanese Lead Extraction Registry
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
- Proportion of procedural success
研究概览
简要总结
Japanese Lead Extraction (J-LEX) Registry is an observational nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center. The acute success rate at discharge and the complications associated with transvenous lead extraction will be collected. J-LEX registry will provide a reliable information on indications, methods, the success rate, complications and the prognosis at 30 days prognosis.
详细描述
Japanese Lead Extraction (J-LEX) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society, collaborated with National Cerebral and Cardiovascular Center. This study is a voluntary nationwide registry and data are collected prospectively using a Research Electronic Data Capture (REDCap) system until 30 days after the lead extraction. The investigators will collect the data regarding patient's background and lead characteristic, medical history, details about lead extraction procedure, lead characteristics, and outcomes. The data were anonymized in a linkable manner at each study site before they were sent. Based on the provided information, the annual incidence and predictive factors for outcome will be investigated by the event assessment committee.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing transvenous lead extraction in Japan.
排除标准
- •Patients who receive open-chest surgical extraction alone.
- •Patients who refused to consent.
结局指标
主要结局
Proportion of procedural success
时间窗: Through discharge from hospital, approximately up to 2 weeks.
Procedural success was defined as complete or partial and is identified for each lead extracted.
次要结局
- Number of patients with procedure-related complications(4 weeks)
- Number of in-hospital deaths(Through discharge from hospital, approximately up to 2 weeks.)
研究者
Kengo Kusano
Director of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
National Cerebral and Cardiovascular Center, Japan