NCT06700174招募中不适用
A Multicenter, Prospective, Single-arm, Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Sizing success rate
研究概览
简要总结
The objective of this PMCF study is to:
- confirm the safety and performance of the AcuMarkTM Sizing Balloon
- identify previously unknown side-effects
- monitor the identified side-effects (related to the procedure or to the medical devices)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography;
- •The anatomy of ASD is suitable for percutaneous closure;
- •Patients are scheduled to perform ASD closure;
- •Patients or legally authorized representative(s) who are willing and capable of providing informed consent.
排除标准
- •Any contraindication for ASD closure;
- •Patients have ostium primum ASD or coronary sinus ASD;
- •Patients who are pregnant or breastfeeding;
- •Patient is currently participating in another clinical trial that has not yet completed its primary endpoint.
结局指标
主要结局
Sizing success rate
时间窗: At procedure
The size of the selected occluder is proper by echocardiography observing
Incidence of major adverse events (MAEs)
时间窗: From attempted procedure to discharge, up to 14 days
Major adverse events are defined as stroke, occluder embolization, arrhythmia, thromboembolic event, oversizing of the defect, cardiac tamponade, and other procedure and/or device-related complications requiring re-intervention.
次要结局
- Device success rate(At procedure)
- Incidence of procedure and/or device-related complications(From attempted procedure to discharge, up to 14 days)
- Incidence of Serious Adverse Events(From attempted procedure to discharge, up to 14 days)
- Incidence of Device Deficiency (DD)(From attempted procedure to discharge, up to 14 days)
研究者
研究点 (5)
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