Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 100
- 主要终点
- Percent of Subjects With Two-year Device-related Hemodynamic Compromise
研究概览
简要总结
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all inclusion criteria. A patient meets inclusion criteria if he/she:
- •is indicated for implantation with the AMPLATZER Septal Occluder for occlusion of a secundum atrial septal defect (Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure),
- •is willing and able to complete the follow-up requirements of this study, and
- •signs the informed consent (or a legal representative signs the informed consent).
排除标准
- 未提供
研究组 & 干预措施
AMPLATZER Septal Occluder
Subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).
干预措施: AMPLATZER Septal Occluder (Device)
结局指标
主要结局
Percent of Subjects With Two-year Device-related Hemodynamic Compromise
时间窗: 24 months
The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.
Co-Primary Effectiveness Endpoint
时间窗: 24 months
The percentage of subjects for whom closure success is achieved through two-years. To meet this endpoint, two criteria must be met: Technical Success: Successful deployment of the device percutaneously Closure Success: Closure of the atrial septal defect (i.e., a shunt \< 2mm) without the need for surgical repair
Co-Primary Safety Endpoint
时间窗: 24 months
The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event
次要结局
未报告次要终点