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

NCT02724709 | Completed DMC

• 1 other identifier: 2016-096
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease

Keywords

Automatic Data Processing; Three-Dimensional Echocardiography; Aortic Valve

Outcome Measures

Primary Outcomes (1)

• Accuracy

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

  Through study completion, an average of 1 month

Secondary Outcomes (2)

• Cost

  Through study completion, an average of 1 month

• Labor time

  Through study completion, an average of 1 month

Interventions

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)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (5)

• Garcia-Martin A, Lazaro-Rivera C, Fernandez-Golfin C, Salido-Tahoces L, Moya-Mur JL, Jimenez-Nacher JJ, Casas-Rojo E, Aquila I, Gonzalez-Gomez A, Hernandez-Antolin 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.

  PMID: 26320167 BACKGROUND

• 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.

  PMID: 23233743 BACKGROUND

• 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.

  PMID: 26977308 BACKGROUND

• 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.

  PMID: 25772834 BACKGROUND

• 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.

  PMID: 31297671 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Hao Wang, M.D.

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Radiologic Imaging

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: March 31, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 9, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)