NCT05887700招募中不适用
A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 145
- 试验地点
- 12
- 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 clinical use of the Lifetech CeraFlex™ Closure System 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 in 2019 or later.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device as per IFU instructions.
- •Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.
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
Procedural success is defined as a composite of: 1. Absence of stroke/TIA, device embolization, cardiac or vascular perforation or device/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 Deficiencies (DD)(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)
- Incidence of device or procedure related Serious Adverse Events (SAEs)(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)
研究者
研究点 (12)
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