ACTRN12613000308796已完成未知
A Pilot Study to evaluate Safety and Efficacy of the Adapt Pericardial Patch in the repair of defects associated with Congenital Heart Disease in participants aged between 1 and 12 years of age.
A/Professor Christian Brizard0 个研究点目标入组 40 人开始时间: 2013年3月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 1 Days 至 12 Years（—）
- 性别
- All
入选标准
- •1. Between the ages of 1 day and 12 years at the time or enrolment.
- •2. Has a congenital heart disease (including ventricular septal defect repair (VSD), atrial ventricular septal defect repair (VSD), atrio ventricular septal defects (AVSD) as determined by clinical assessment including echo cardiography and/or MRI
- •3. Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the subject's behalf.
- •4. Willing and able to complete all study visits and procedures
排除标准
- •1. Has a clinically confirmed infection
- •2. Has co-morbidities which are likely to lead to death within the study follow up period.
- •3. Is participating in another study.
- •4. Is likely to require additional surgical intervention using a bioprosthetic material.
- •5. Unwilling or unable to comply with treatment follow up requirements.
- •6. Any other clinical condition which leads the investigator to consider the subject unsuitable for enrolment into the study.
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