Relationship Between Key Factors of Leadless Pacemaker Implantation With Implantation Site, Intraoperative Complications and Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Serious adverse events
研究概览
简要总结
To investigate the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis.
详细描述
In this study, we aim to include patients implated with leadless pacemakers, collect key variables and other clinical data during implantation of leadless pacemakers, and observe the final implantation site, intraoperative complications and prognosis information of patients. This study aims to clarify the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis, and provide data support for the standardization of leadless pacemaker implantation process in China.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient received implantation of leadless pacemaker
- •Patient agreed to join into this study and signed informed consent
排除标准
- •Age < 18 years
- •Ventricular septal defect
- •History of mechanical tricuspid valve replacement
- •History of inferior vena cava filter placement
- •Pregnant or plan to be pregnant within 2 years
- •Life expectancy < 1 year
- •Patient was included in other studies that could introduce bias into this study
结局指标
主要结局
Serious adverse events
时间窗: Day 0 (Time of implantation)-Day 7
including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection
次要结局
- Serious adverse events(Day 0 (Time of implantation)-Year 2)
- Re-intervention of devices(Day 0 (Time of implantation)-Year 2)
- Device-related complications(Day 0 (Time of implantation)-Year 2)
研究者
Yangxin Chen
Chief physician
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University