跳至主要内容
临床试验/DRKS00010233
DRKS00010233已完成不适用

Multi-Centre Trial to Evaluate the Clinical Performance of the Lifetech/Medtronic Ceraflex-ASD-Occluder for Transcatheter Closure of Secundum Atrial Septal Defects - Ceraflex-ASD-Occluder

Deutsches Herzzentrum München0 个研究点目标入组 149 人开始时间: 2016年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
149

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
one 至 one(—)
性别
All

入选标准

  • Able to fluently speak and understand German language, existent ostium secundum atrial septal defect (ASD II), presence of a hemodynamically significant ASD II (right ventricular volume overload determined by transthoracic echo (TTE)), defect hole(s) to be covered by an available Ceraflex ASD device, sufficient margin to place the device, Informed Consent prior to treatment and willing to return for the post-treatment evaluation at the implanting institution after 6 month

排除标准

  • presence of multiple defects which cannot adequately covered by implantation of one device, current participation in another ongoing clinical device or drug trial, recent myocardial infarction, unstable angina and decompensated congestive heart failure (CHF), active bacterial and/or viral infection, evidence of intra-cardiac thrombi on echocardiography, any existent disorder that, in opinion of the investigator, might interfere with the conduct of the trial

研究者

发起方
Deutsches Herzzentrum München

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