Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Determine change from baseline in exercise capacity after Fontan stenting.
研究概览
简要总结
The goal of this observational study is to assess the clinical impact following Fontan stent placement for extracardiac Fontan conduit (EFC) stenosis in patients with single-ventricle Fontan-palliated patients ages 12-21 years old.
The main question it aims to:
-Assess changes in exercise capacity by cardiopulmonary exercise testing and liver stiffness assessed by shear wave elastography before and after EFC stenting.
Participants will undergo two cardiopulmonary exercise tests and three shear wave elastography scans.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functionally single-ventricle Fontan-palliated patients undergoing clinically indicated cardiac catheterization
- •Anticipated Fontan stent placement for extracardiac Fontan conduit stenosis at the discretion of the primary operator
- •Weight ≥ 50 kg
- •12-21 years of age
排除标准
- •Interrupted IVC
- •Greater than mild atrioventricular valve regurgitation on most recent echocardiogram or MRI (RF > 20%).
- •Greater than mild systemic ventricular dysfunction on most recent echo or MRI (EF < 40%).
- •Non-sinus rhythm
- •Pacemaker
- •Inability to perform exercise test due to developmental or physical disability
结局指标
主要结局
Determine change from baseline in exercise capacity after Fontan stenting.
时间窗: 1 year post enrollment
Peak oxygen consumption (VO2) as measured by Vyntus CPX metabolic cart.
Determine changes from baseline in liver stiffness as measured by shear wave elastography after Fontan stenting.
时间窗: 1 year post enrollment
FibroScan will be used to assess liver stiffness before catheterization, at 2-4 weeks following stent placement, and 3-6 months following stent placement.
次要结局
未报告次要终点
研究者
Neil Patel
Medical Staff/USC Faculty CWR • Cardiology CWR
Children's Hospital Los Angeles