NCT05893758已完成不适用
A Real-world Registry Assessing the Clinical Use of the Lifetech Cera™ PFO Occluder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 5
- 主要终点
- Incidence of stroke/TIA, procedure/device-related death and serious procedure/device complications
研究概览
简要总结
The objective of this post-market registry is to assess the clinical use of the Lifetech Cera™ PFO Occluder in a real-world and on-label fashion.
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 Patent Foramen Ovale (PFO);
- •Associated with TIA or cryptogenic stroke;
- •Patients was 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
- •Any contraindication mentioned in the corresponding IFU;
- •Patients did not conduct any follow up visit after hospital discharge.
结局指标
主要结局
Incidence of stroke/TIA, procedure/device-related death and serious procedure/device complications
时间窗: from attempted procedure to 24 months post-implantation.
Serious procedure/device complications include device embolization, cardiac or vascular perforation, atrial fibrillation, device thrombosis, pulmonary embolism and deep vein thrombosis.
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 death(from attempted procedure to 24 months post-implantation)
- Successful closure of the PFO, confirmed by contrast Transcranial Doppler (cTCD), defined as with no, small or moderate residual shunt(at procedure, 6 months and 12 months post-implantation)
- Incidence of device or procedure related Serious Adverse Events (SAEs)(from attempted procedure to 24 months post-implantation)
研究者
研究点 (5)
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