Follow Up on Freestyle Valves for Right Ventricular Outflow Tract Reconstruction in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- We hypothesize that this Medtronic Freestyle® porcine aortic root valve has good long term hemodynamic performance and longevity.
研究概览
简要总结
The purpose of this study is to determine if the Medtronic Freestyle porcine valve is effective over a long period of time when it is used to replace the valve that normally allows blood to flow from the right lower pumping chamber of the heart to the lungs.
详细描述
During the time between June 1998 and June 2006, the Medtronic Freestyle® porcine aortic root (Medtronic, Minneapolis, MN) was used for reconstruction of the right ventricular outflow tract in children that underwent surgery at Children's Healthcare of Atlanta. These children were born with heart problems that made it difficult for blood to flow from the lower right chamber of the heart to the lungs where it would normally pick up oxygen to be used by the body. Consequently, these children required surgery to repair the valve and eliminate this restriction of blood flow to the lungs in order to preserve life. In this case, the Freestyle valve was used. It is a relatively new valve and it is not known how it functions and how it impacts overall heart function over a long period of time. We are requesting permission to recruit volunteers that have received the Freestyle valve for this purpose in order to determine its long term performance. Specifically, we are seeking volunteers that are willing to have an echocardiogram performed. It is through the evaluation of a recent echocardiogram, as it compares to previous echocardiograms performed on the same patient, that the usefulness of the Freestyle valve will be evaluated for its durability and its long term impact on heart function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 40 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
We hypothesize that this Medtronic Freestyle® porcine aortic root valve has good long term hemodynamic performance and longevity.
时间窗: Retrospective Chart Review
Retrospective Chart Review
次要结局
未报告次要终点
研究者
Kirk R. Kanter, MD
Chief, Pediatric Cardiac Surgery
Emory University
