Clinical trial NCT02724709: Semi-automatic assessMent of Aortic Roots by Three-dimensional transoEsophageal echocaRdiography (SMARTER)
Official title: Semi-automatic assessMent of Aortic Roots by Three-dimensional transoEsophageal echocaRdiography (SMARTER)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Keywords: Automatic Data Processing
Three-Dimensional Echocardiography
Aortic Valve
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: Siemens Corporation, Corporate Technology
First posted: 2016-03-31
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical normal aortic valve and root, who are indicated for both transesophageal echocardiography (TEE) and computed tomographic (CT) due to atrial fibrillation or patent foramen ovale.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: Cost
timeFrame: Through study completion, an average of 1 month
measure: Labor time
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Hao Wang, M.D.
role: STUDY_CHAIR
References:
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citation: Calleja A, Thavendiranathan P, Ionasec RI, Houle H, Liu S, Voigt I, Sai Sudhakar C, Crestanello J, Ryan T, Vannan MA. Automated quantitative 3-dimensional modeling of the aortic valve and root by 3-dimensional transesophageal echocardiography in normals, aortic regurgitation, and aortic stenosis: comparison to computed tomography in normals and clinical implications. Circ Cardiovasc Imaging. 2013 Jan 1;6(1):99-108. doi: 10.1161/CIRCIMAGING.112.976993. Epub 2012 Dec 10.
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citation: Hahn RT, Little SH, Monaghan MJ, Kodali SK, Williams M, Leon MB, Gillam LD. Recommendations for comprehensive intraprocedural echocardiographic imaging during TAVR. JACC Cardiovasc Imaging. 2015 Mar;8(3):261-287. doi: 10.1016/j.jcmg.2014.12.014.
citation: Zhang M, Wan L, Liu K, Wu W, Li H, Wang Y, Lu B, Wang H. Aortic roots assessment by an automated three-dimensional transesophageal echocardiography: an intra-individual comparison. Int J Cardiovasc Imaging. 2019 Nov;35(11):2029-2036. doi: 10.1007/s10554-019-01664-z. Epub 2019 Jul 11.