Allogeneic Valve Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Valve Annulus Growth
研究概览
简要总结
Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.
详细描述
Heart valves in children and young adults may need replacement or repair. In many children the options for heart valve replacement do not grow as the child grows. A transplanted valve may have the option to grow with time and may reduce the need for multiple operations over a lifetime. This trial will study the outcomes of heartfelt transplant in children and young adults undergoing this procedure. The study will look at outcomes of valve transplant and any potential side effects.
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
- 30 Days 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Valve Annulus Growth
时间窗: One Year
Measurement of valve annulus via echocardiogram, CT scan and MRI. This will be quantified by whether or not the annulus continues to increase in size as the subject grows.
Valve Regurgitation
时间窗: One year
Heart valve regurgitation by echocardiogram. The degree of regurgitation is read and quantified by an echocardiologist.
Leaflet Growth
时间窗: One Year
Measurement of leaflet height via echocardiogram, CT scan and MRI and reviewed by an echocardiologist. This will be analyzed by whether or not the leaflets continue to grow in size, with the subject.
次要结局
- Survival(5 years)
- Ventricular Function(One year)
研究者
Sitaram Emani
Associate Professor of Surgery
Boston Children's Hospital