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

Completed

• Conditions: Aortic Valve Disease

• Registration Number: NCT02724709
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-03-25
• Study First Posted: 2016-03-31
• Primary Completion: 2016-07
• Status Verified: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy	Through study completion, an average of 1 month	Compare semi-automatic assessment of 3D TEE to CT measurement

Secondary Outcome Measures

Name	Time	Method
Cost	Through study completion, an average of 1 month	Compare cost between 3D TEE and CT
Labor time	Through study completion, an average of 1 month	Compare labor time between 3D TEE and CT

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China