Natural History of Melody Valve in the Mitral and Tricuspid Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Long term durability of Melody Valve in mitral and tricuspid positions, to be measured by degree of stenosis in Melody valve
研究概览
简要总结
The Melody valve has historically been used for pulmonary valve replacements; however it has been more recently used in the mitral and tricuspid positions. This multi-center, retrospective, observational study will review the durability of the Melody valve inserted into the mitral or tricuspid positions.
Patients who have undergone Melody valve insertion into either the mitral or tricuspid positions prior to December, 2014 will be eligible for the study. Basic de-identified patient demographics will be collected as well as select clinical data. Ventricular function and valvar function of the affected valve will be retrospectively reviewed both prior to surgery and following, as well as review of operative data. The investigators will also review the most recent follow up data and any subsequent re-interventions on the Melody valve. Data from all sites will be entered into an external REDCap database, using only de-identified data.
详细描述
Prior to recent advancement in using the Melody valve for atrioventricular valve replacement, there have only been fixed diameter valve options for severe valve disease requiring replacement. This presents numerous obstacles for those pediatric patients who require replacement early in life, as the fixed diameter does not offer options for expansion for somatic growth, and early reoperation will be required.
The Melody valve has been approved for transcatheter implantation into the RVOT (right ventricular outflow tract), and has shown competence within a range of sizes. Recent studies conducted at Boston Children's Hospital of off-label use of the Melody valve into atrioventricular valve positions have shown acceptable short-term valve performance, and that subsequent catheter-based expansion is feasible.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who have had a Melody valve inserted into either mitral or tricuspid positions via surgical intervention
排除标准
- •There are no exclusion criteria.
结局指标
主要结局
Long term durability of Melody Valve in mitral and tricuspid positions, to be measured by degree of stenosis in Melody valve
时间窗: up to 5 years
Long term durability of Melody Valve in mitral and tricuspid positions, to be measured by grade of regurgitation in Melody valve
时间窗: up to 5 years
Long term durability of Melody Valve in mitral and tricuspid positions, to be measured by number of necessary re-interventions of Melody valve
时间窗: up to 5 years
次要结局
未报告次要终点
研究者
Sitaram Emani
Cardiovascular Surgeon
Boston Children's Hospital