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临床试验/NCT02724709
NCT02724709已完成不适用

Semi-automatic assessMent of Aortic Roots by Three-dimensional transoEsophageal echocaRdiography (SMARTER)

Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
77
试验地点
1
主要终点
Accuracy

研究概览

简要总结

The progress in surgery of the aortic root and the evolution of transcatheter aortic valve replacement as an alternative to surgical treatment in selected patients have refocused the need for quantitative imaging of the aortic root during transcatheter aortic valve replacement and valve-sparing aortic root surgery. In this study, we aim to assess the ability of semi-automated quantitative modeling (eSie Valves, Autovalve prototype version, Siemens Medical Solutions, USA) of the aortic valve and root in patients with clinical normal aortic valve and root, who are indicated for both 3D transesophageal echocardiography (TEE) and computed tomographic (CT) due to atrial fibrillation or patent foramen ovale. Measures of the aortic valve and root obtained by 2D TEE, 3D TEE and CT are compared, and the ability of the semi-automated 3D TEE modeling software is tested. Given the workflow advantages of automation, this 3D TEE approach may enhance the clinical adoption of routine 3-dimensional imaging beyond CT.

详细描述

Recent developments in aortic root interventions have focused on the need for 3-dimensional imaging of the aortic functional anatomy. The progress in surgery of the aortic root and the evolution of transcatheter aortic valve replacement as an alternative to surgical treatment in selected patients have refocused the need for quantitative imaging of the aortic root during transcatheter aortic valve replacement and valve-sparing aortic root surgery. In this study, we aim to assess the ability of semi-automated quantitative modeling (eSie Valves, Autovalve prototype version, Siemens Medical Solutions, USA) of the aortic valve and root in patients with clinical normal aortic valve and root, who are indicated for both 3D transesophageal echocardiography (TEE) and computed tomographic (CT) due to atrial fibrillation or patent foramen ovale. Measures of the aortic valve and root obtained by 2D TEE, 3D TEE and CT are compared, and the ability of the semi-automated 3D TEE modeling software is tested. Given the workflow advantages of automation, this 3D TEE approach may enhance the clinical adoption of routine 3-dimensional imaging beyond CT.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • both transesophageal echocardiography (TEE) and computed tomographic (CT) are referred by cardiologists
  • apparent normal aortic valve and root structure
  • written consent

排除标准

  • post-operation of aortic valve
  • severe cardiomyopathy
  • cardiac functional insufficiency (NYHA III or IV)
  • contraindications for either TEE or cardiac CT angiography

结局指标

主要结局

Accuracy

时间窗: Through study completion, an average of 1 month

Compare semi-automatic assessment of 3D TEE to CT measurement

次要结局

  • Cost(Through study completion, an average of 1 month)
  • Labor time(Through study completion, an average of 1 month)

研究者

发起方
Chinese Academy of Medical Sciences, Fuwai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bin Lu

Professor and Director of Radiologic Imaging

Chinese Academy of Medical Sciences, Fuwai Hospital

研究点 (1)

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