Semi-automatic assessMent of Aortic Roots by Three-dimens... | NCT02724709

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

NCT02724709

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Completed

Last Update Posted

Aug 9, 2016Estimated

Enrollment

77Actual

Phase

Not provided

Conditions

Aortic Valve Disease

Interventions

Three-dimensional transoesophageal echocardiography
Computed tomography

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Jul 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Mar 21, 2016

First Submission Date that Met QC Criteria

Mar 25, 2016

First Posted Date

Mar 31, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2016

Last Update Posted Date

Aug 9, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bin Lu, Professor and Director of Radiologic Imaging, Chinese Academy of Medical Sciences, Fuwai HospitalPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

Collaborators

Name	Class
Siemens Corporation, Corporate Technology	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hao Wang, M.D.	Chinese Academy of Medical Sciences, Fuwai Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fuwai Hospital		Beijing	Beijing Municipality	100037	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26320167	Background	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.
23233743

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases