Assessment of the Impact of Transcatheter Stenting of Aortic Coarctation on the Left Ventricular Afterload and Work Using Left Ventricular Pressure Volume Loops
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- Change in left ventricular afterload measured by arterial elastance
研究概览
简要总结
Coarctation of the aorta accounts for 4-7% of all congenital heart disease. While stent therapy, when feasible, is the standard of care for coarctation, it may not completely improve the work (and afterload) of the heart due to its effects on the elasticity of the aorta. This study will provide the information needed to understand the effects of current management on the cardiac mechanics and work.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 6 years of age and older and adults of all races and both sexes referred for elective cardiac catheterization and stent therapy for coarctation
- •Those who provide informed consent for study participant.
排除标准
- •Children who undergo other interventions in addition to the coarctation
- •Children with single ventricle physiology.
- •Renal impairment
- •Participant unwilling to sign a consent form.
结局指标
主要结局
Change in left ventricular afterload measured by arterial elastance
时间窗: Immediately following intervention
Arterial elastance (Ea) is measured by the pressure volume (PV) loop catheter in the left ventricle. The PV loop catheter measures pressure and volume simultaneously during the entire cardiac cycle. Arterial elastance is a measure of ventricular afterload and will be calculated using previously described formula; Ea (arterial elastance): Ea = Pend systole/ SV (where P, is pressure at end systole, and SV is stroke volume). Elastance will be reported as a continuous variable in mmHg/mL with a higher number indicating an increase in elastance and a negative number indicating a decrease in elastance. Change in elastance before and after stent placement will be compared using paired T test.
次要结局
- Change in left ventricular performance measured by ESPVR(Immediately following intervention)
- Change in left ventricular efficiency as measured by ventricular arterial coupling(Immediately following intervention)
- Change in left ventricular work as measured by Stroke Work(Immediately following intervention)