临床试验/NCT00578708

NCT00578708已完成1 期

Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER

Abbott Medical Devices11 个研究点分布在 1 个国家目标入组 35 人开始时间: 2003年9月最近更新: 2019年2月4日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Abbott Medical Devices
入组人数: 35
试验地点: 11
主要终点: Closure of perimembranous Ventricular Septal Defects

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this feasibility study is to investigate the safety of the AMPLATZER® Membranous VSD Occluder for the treatment of hemodynamically significant Perimembranous Ventricular Septal Defects.

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 with hemodynamically significant Perimembranous ventricular septal defects

排除标准

•Patients < 8 kg
•Supracristal ventricular septal defects
•Left ventricle to right atrium shunting
•Prolapse of the aortic valve
•Right to left shunting through the defect
•Perimembranous VSD with an aneurysm and multiple shunts which can not be successfully closed with one device
•Patients with <2mm aortic rim
•Sepsis (local/generalized)
•Complex heart lesions such as atrioventricular canal defect or Tetralogy of Fallot.
•Patients who are ASA intolerant
•Unable to be followed for the duration of the clinical trial
•Inability to obtain informed consent

研究组 & 干预措施

1

Experimental

干预措施: AMPLATZER Membranous VSD Occluder (Device)

结局指标

主要结局

Closure of perimembranous Ventricular Septal Defects

时间窗: 5 years

次要结局

未报告次要终点

研究者

发起方

Abbott Medical Devices

申办方类型

Industry

责任方

Sponsor

研究点 (11)

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