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OpenTrials
Completed

NCT Number: NCT02724709

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Three-dimensional transoesophageal echocardiography

Procedure

Three-dimensional transoesophageal echocardiography, analysed by eSie valve software (Siemens)

Computed Tomography

Procedure

Computed tomography, analysed by Synovia Workstation (Siemens)

Primary outcomes

  1. Accuracy

    Time frame: Through study completion, an average of 1 month

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

Secondary outcomes

  1. Cost

    Time frame: Through study completion, an average of 1 month

    Compare cost between 3D TEE and CT

  2. Labor time

    Time frame: Through study completion, an average of 1 month

    Compare labor time between 3D TEE and CT

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Collaborators

  • Siemens Corporation, Corporate Technology

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2016
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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