The Impact of Transcatheter Aortic Valve Implantation on Left Ventricular Structure, Function and Outcome in Patients With Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 主要终点
- The impact of TAVI on left ventriclar mass and hypertrophy regression
研究概览
简要总结
A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who underwent TAVI at the Haukeland university hospital, Bergen, Norway.
详细描述
A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who underwent TAVI at the Haukeland university hospital, Bergen, Norway between January 2012 and July 2019.
Demographics, clinical data including cardiovascular risk factors, arterial and echocardiographic parameters were prospectively collected. The data on all-cause mortality will be collected. Echocardiograms (immediate before TAVI, at discharge after TAVI and at 6-12 months follow-up) will be analyzed. The main scientific objectives are:
To assess survival benefits of TAVI according to baseline risk profile. To determine the echocardiographic predictors of left ventricular mass regression and left ventricular function recovery.
To evaluate global LV load (Zva=valvular-arterial impedance) following TAVI. To assess the impact of various types of blood pressure responses immediately after TAVI on clinical outcomes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodynamically severe aortic stenosis and symptoms
- •A decision of TAVI by Heart team
- •Patients undergoing TAVI (transcatheter aortic valve implantation)
- •Life expectancy > 1-2 years
排除标准
- •Sever frailty
- •Severly reduced cognitive function
- •Multiple comorbid conditions
- •Technically not suited for TAVI
结局指标
主要结局
The impact of TAVI on left ventriclar mass and hypertrophy regression
时间窗: From January 2012 to follow-up echo (6-12 months following TAVI)
To assess whether removal of valve stenosis by TAVI leads to regression of left ventricular mass (grams).
The impact of TAVI on left ventricular function recovery
时间窗: From January 2012 to to follow-up echo (6-12 months following TAVI)
To assess improvement in systolic function (increase in ejection fraction) following TAVI
The impact of TAVI on arterial load (systemic arterial stiffness and arterial compliance).
时间窗: From January 2012 to to follow-up echo (6-12 months following TAVI)
To assess improvement in echocardiographic arterial stiffness and arterial compliance and global left ventricular load (Zva=valvular-arterial impedance) following TAVI.
The impact of TAVI on all-cause mortality
时间窗: From January 2012 to Mai 2020 (date for assesment vital status) + prolonged follow-up (up to 10 years)
To assess the long-term survival benefits of TAVI
次要结局
未报告次要终点