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

Aortic Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724709
• Other study ID #: 2016-096
• Status: Completed
• Phase: N/A
• First received: March 21, 2016
• Last updated: August 8, 2016
• Start date: March 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Procedure:
• Three-dimensional transoesophageal echocardiography
Three-dimensional transoesophageal echocardiography, analysed by eSie valve software (Siemens)
• Computed tomography
Computed tomography, analysed by Synovia Workstation (Siemens)

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital	Siemens Corporation, Corporate Technology

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

Chambers JB, Myerson SG, Rajani R, Morgan-Hughes GJ, Dweck MR. Multimodality imaging in heart valve disease. Open Heart. 2016 Mar 8;3(1):e000330. doi: 10.1136/openhrt-2015-000330. eCollection 2016. Review. — View Citation

García-Martín A, Lázaro-Rivera C, Fernández-Golfín C, Salido-Tahoces L, Moya-Mur JL, Jiménez-Nacher JJ, Casas-Rojo E, Aquila I, González-Gómez A, Hernández-Antolín R, Zamorano JL. Accuracy and reproducibility of novel echocardiographic three-dimensional automated software for the assessment of the aortic root in candidates for thanscatheter aortic valve replacement. Eur Heart J Cardiovasc Imaging. 2016 Jul;17(7):772-8. doi: 10.1093/ehjci/jev204. Epub 2015 Aug 27. — View 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):261-87. doi: 10.1016/j.jcmg.2014.12.014. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy	Compare semi-automatic assessment of 3D TEE to CT measurement	Through study completion, an average of 1 month	No
Secondary	Cost	Compare cost between 3D TEE and CT	Through study completion, an average of 1 month	No
Secondary	Labor time	Compare labor time between 3D TEE and CT	Through study completion, an average of 1 month	No

External Links

•   Introduction of eSie Valves technology