Safety and Effectiveness of Implantable Loop Recorder in Patients With Recurrent, Unexplained, Traumatic Syncope
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 488
- 主要终点
- Traumatic syncope recurrence
研究概览
简要总结
Prospective, observational registry enrolling consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation with the aim to evaluate the incidence of recurrence of traumatic syncope during follow-up.
详细描述
This observational, prospective registry enrolled consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation according to current clinical practice. The patients were evaluated every 6 months based on current clinical practice and the risk of recurrence of traumatic syncope was assessed during follow-up.
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
- •patients with recurrent, unexplained, traumatic syncope
- •patients underwent implantable loop recorder implantation
排除标准
- •patients unable to attend scheduled outpatient visits
结局指标
主要结局
Traumatic syncope recurrence
时间窗: through study completion, an average of 2 year
Incidence of traumatic syncope recurrence
次要结局
未报告次要终点
研究者
Pietro Palmisano
MD
Azienda Ospedaliera Cardinale G. Panico