Clinical Outcome of Patients With Low Ejection Fraction or Low-gradient Severe Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in left ventricular ejection fraction after aortic valve replacement
研究概览
简要总结
To assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with low-gradient, severe aortic stenosis.
To assess the impact of aortic valve replacement as compared to medical therapy on clinical outcome of patients with low-gradient, severe aortic stenosis.
To assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities on the assessment of AS severity and definition of low gradient severe aortic stenosis.
详细描述
To assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with impaired left ventricular function and / or low-gradient, severe aortic stenosis.
To assess the impact of aortic valve replacement as compared to medical therapy on clinical outcome of patients with impaired left ventricular function and / or low-gradient, severe aortic stenosis.
To assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities on the assessment of AS severity and definition of low gradient severe aortic stenosis.
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
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 and low gradient (mean gradient across the aortic valve <40 mmHg) by echocardiography
- •Symptomatic patients with aortic stenosis referred for medically indicated AVR
- •Signed informed consent to participate in the study.
排除标准
- •Pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test).
- •Need for emergency surgery for any reason.
- •Any case in which the practicing physician asserts that enrollment in the protocol will adversely affect the patient treatment course.
结局指标
主要结局
Change in left ventricular ejection fraction after aortic valve replacement
时间窗: 2±1 months
次要结局
未报告次要终点