Partial Heart Transplantation for Severe Pediatric Semilunar Valve Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of eligible patients who can be matched for transplant and the tissues needed procured
研究概览
简要总结
The purpose of this study is to determine if a partial heart transplantation in patients with congenital heart disease is safe and feasible. Participants will have a partial heart transplant involving surgical replacement of the pulmonary valve with the heart valve and supporting blood vessels from an organ donor. The procedure, tests, medications, and follow-up visits will all be done per standard of care. Medical data will be collected to look at outcomes after surgery.
详细描述
The purpose of this study is to determine if a partial heart transplantation in patients with congenital heart disease is safe and feasible. Potential participants are patients 12 and younger with congenital heart defects in need of pulmonary valve replacement.Participants will have a partial heart transplant involving surgical replacement of the pulmonary valve with the heart valve and supporting blood vessels from an organ donor. The study procedure, tests, medications, and follow-up visits will all be done per standard of care for heart transplant patients. Data will be collected from chart review, before, during and after surgery and at standard of care follow-up visits. Study data will be compared to historical data of patients who have undergone other types of pulmonary valve replacement surgery.
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
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital heart patient referred for a cardiac operation that involves valve replacement in pulmonary position
- •Deemed acceptable for partial heart transplantation based on the standard evaluation process
排除标准
- •Contraindication for heart transplantation
- •Severe bliateral long segment pulmonary arterial hypoplasia
- •Bilateral pulmonary vein stenosis
- •Persistent acidosis with a pH < 7.1
- •Failure to pass psychosocial evaluation
- •Parental (custodial) alcohol and/or substance abuse
- •Documented parental (custodial) child abuse or neglect
- •Parent (custodian) with cognitive/psychiatric impairment severe enough to limit comprehension of medical regimen
- •Infection disease exclusion criteria
- •Evidence of active sepsis
- •Hepatitis B surface antigenemia
- •HIV positivity
- •Pregnancy
- •Financial hardship or insurance non-approval
研究组 & 干预措施
Partial Heart Transplantation
Participants will receive a partial heart transplantation to replace the pulmonary valve with fresh donor graft(s). This is an investigational procedure. This means this procedure is not done as a routine treatment for patients with congenital heart defects. Partial heart transplantation involves surgical replacement of the semilunar heart valve with the heart valve and supporting blood vessels and tissue from an organ donor. No other parts of the heart are transplanted besides the heart valve, blood vessel, and tissue surrounding the valve.
干预措施: Partial Heart Transplantation (Procedure)
Partial Heart Transplantation
Participants will receive a partial heart transplantation to replace the pulmonary valve with fresh donor graft(s). This is an investigational procedure. This means this procedure is not done as a routine treatment for patients with congenital heart defects. Partial heart transplantation involves surgical replacement of the semilunar heart valve with the heart valve and supporting blood vessels and tissue from an organ donor. No other parts of the heart are transplanted besides the heart valve, blood vessel, and tissue surrounding the valve.
干预措施: Freshly procured valve (Other)
结局指标
主要结局
Number of eligible patients who can be matched for transplant and the tissues needed procured
时间窗: Day 1
A measure of feasibility.
To assess valve growth following partial heart transplantation.
时间窗: Year 2
This will be determined by looking at valve growth compared to body growth over time based on post-operative imaging.
次要结局
- To assess valve function following partial heart transplantation.(Year 2)
- To determine whether valve replacement(s) using partial heart transplantation is safe.(Year 2)