Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 49
- 主要终点
- The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.
研究概览
简要总结
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
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
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have diagnosis of a PDA
- •Subject must have a PDA < 5.5mm in diameter by angiography
- •Subject must have a PDA < 12mm in length by angiography
- •Subject must have a PDA > 3mm in length by angiography
- •Subject/legally authorized representative must give consent to participate in the clinical study
- •Subject/legally authorized representative must consent to follow-up for the duration of the clinical study
排除标准
- •Subject must not be < 6 kilograms for the procedure
- •Subject must not be < 6 months of age
- •Subject must not be ≥ 18 years of age
- •Subject must not have a descending aorta < 10mm in diameter
- •Subject must not have a right to left shunt through the patent ductus arteriosus
- •Subject must not have PVR above 8 Woods units or a Rp/Rs >0.4
- •Subject must not have intracardiac thrombus
- •Subject must not have additional cardiac anomalies requiring surgical or interventional correction
- •Subject must not have history of more than two lower respiratory infections within the last year (i.e., pneumonia)
- •Subject must not have active infection requiring treatment at the time of implant
- •Subject must not have contraindication to anticoagulation treatment
- •Female subjects of child bearing age must not be pregnant or desire to become pregnant within six months post implant*
- •Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints
- •If the subject desires to become pregnant after six months post-implant, further restriction is at the discretion of their physician.
研究组 & 干预措施
Device
干预措施: AMPLATZER Duct Occluder II (Device)
结局指标
主要结局
The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.
时间窗: 180 days
The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively.
The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.
时间窗: 180 days
The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event.
次要结局
未报告次要终点