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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02724709
Enrollment
77
Registered
2016-03-31
Start date
2016-03-31
Completion date
2016-08-31
Last updated
2016-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease

Keywords

Automatic Data Processing, Three-Dimensional Echocardiography, Aortic Valve

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREThree-dimensional transoesophageal echocardiography

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

PROCEDUREComputed tomography

Computed tomography, analysed by Synovia Workstation (Siemens)

Sponsors

Siemens Corporation, Corporate Technology
CollaboratorINDUSTRY
Chinese Academy of Medical Sciences, Fuwai Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
AccuracyThrough study completion, an average of 1 monthCompare semi-automatic assessment of 3D TEE to CT measurement

Secondary

MeasureTime frameDescription
CostThrough study completion, an average of 1 monthCompare cost between 3D TEE and CT
Labor timeThrough study completion, an average of 1 monthCompare labor time between 3D TEE and CT

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026