A Multi-center, Single Arm, Real-World Registry Assessing the Clinical Use of the Cera™ VSD Occluder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 8
- 主要终点
- Procedural success
研究概览
简要总结
The objective of this post-market registry is to assess the safety and performance of the Lifetech Cera™ VSD occluder in a real-world and on-label fashion.
详细描述
The study intends to collect data from patients who have implanted with the device before 2022. The study is expected to completed by the end of 2024.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the investigational device as per IFU instructions
排除标准
- •Patients did not conduct any follow up visit after hospital discharge.
结局指标
主要结局
Procedural success
时间窗: 6 months post-implantation
Defined as a composite of: 1. Absence of complete atrioventricular block (third degree AV block) needing pacemaker implantation, device embolization, severe aortic regurgitation requiring surgical repair or device or procedure related death, assessed at 6 months post-implantation. 2. Successful closure of the defects, with no, trivial or small residual shunt confirmed by Doppler echocardiography at 6 months post-implantation .
次要结局
- Incidence of device or procedure related Serious Adverse Events (SAEs)(from attempted procedure to 24 months post-implantation)
- Incidence of Device Deficiencies (DD)(from attempted procedure to 24 months post-implantation)
- Incidence of new onset second-degree AV block(from attempted procedure to 24 months post-implantation)
- Incidence of new onset severe aortic or tricuspid regurgitation(from attempted procedure to 24 months post-implantation)
- Incidence of moderate or large residual shunt(at procedure, 6 months and 12 months post-implantation)
- Incidence of death(from attempted procedure to 24 months post-implantation)
- Incidence of new onset complete AV block (third-degree AV block) or any new onset arrhythmia needing for pacemaker implantation, or new onset left bundle branch block (LBBB);(from attempted procedure to 24 months post-implantation)
- Incidence of device-related thrombosis (DRT)(from attempted procedure to 24 months post-implantation)
- Incidence of device embolization(from attempted procedure to 24 months post-implantation)
- Incidence of device or procedure related Adverse Events (AEs)(from attempted procedure to 24 months post-implantation)