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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Aortic Valve Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Three-dimensional transoesophageal echocardiography

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

Intervention Type PROCEDURE

Computed tomography

Computed tomography, analysed by Synovia Workstation (Siemens)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No