NCT01966146已完成不适用
Quantitative Analysis of Catheter-based Interventional Therapies for Treating Valve Insufficiency by Using 3D Echocardiography.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Quantitative analysis of geometric changes and heart function after heart valve replacement and reconstruction respectively by 3D echocardiographic procedures
研究概览
简要总结
Aim of the study is the definition of criteria for a standardized assessment of heart function by 3D echocardiographic procedures. Standardized criteria will be defined to assess aortic valve insufficiency after TAVI and success of mitral valve replacement respectively.
详细描述
Echocardiography: GE Healthcare Vivid E9
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •patients with severe symptoms of an aortic stenosis who underwent catheter based implantation of an aortic valve
- •patients who are planned to undergo a reconstruction of the mitral valve with the MitraClip System
- •Patients who are aged above 18 years and legally competent
- •signed informed consent
排除标准
- •patients with previous myocard infarction, previous heart surgeries, malignity or valvular abnormities > stage 1
- •patients with atrial fibrillation
- •pregnant and breast-feeding women
- •patients with disturbed central nerve system
- •patients with pacemaker, implants, ferrous clamps,insulin pump
- •patients with tattoo
- •patients with claustrophobia
- •patiens with asthma
研究组 & 干预措施
TAVI
Experimental
Echocardiography after TAVI
干预措施: Echography GE Healthcare Vivid E9 (Device)
MitraClip
Experimental
Echocardiography after MitraClip procedure
干预措施: Echography GE Healthcare Vivid E9 (Device)
结局指标
主要结局
Quantitative analysis of geometric changes and heart function after heart valve replacement and reconstruction respectively by 3D echocardiographic procedures
时间窗: Analysis will be performed after heart valve replacement or reconstruction procedures and after 6 month
次要结局
未报告次要终点
研究者
研究点 (1)
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