Aortic Valve DiseaseNCT02724709
Semi-automatic assessMent of Aortic Roots by Three-dimensional transoEsophageal echocaRdiography (SMARTER)
An observational study of Aortic Valve Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Three-dimensional transoesophageal echocardiography and Computed tomography
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Aug 2016
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- both transesophageal echocardiography (TEE) and computed tomographic (CT) are referred by cardiologists
- apparent normal aortic valve and root structure
- written consent
Who cannot join
- post-operation of aortic valve
- severe cardiomyopathy
- cardiac functional insufficiency (NYHA III or IV)
- contraindications for either TEE or cardiac CT angiography
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Aortic Valve Disease
- Being tested
- Three-dimensional transoesophageal echocardiography, Computed tomography
- Keywords
- Automatic Data Processing, Three-Dimensional Echocardiography, Aortic Valve
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional transoesophageal echocardiographyProcedure or surgery
Three-dimensional transoesophageal echocardiography, analysed by eSie valve software (Siemens)
Computed tomographyProcedure or surgery
Computed tomography, analysed by Synovia Workstation (Siemens)
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Compare semi-automatic assessment of 3D TEE to CT measurement
Measured: Through study completion, an average of 1 month
Secondary outcomes (2)
Cost
Compare cost between 3D TEE and CT
Measured: Through study completion, an average of 1 month
Labor time
Compare labor time between 3D TEE and CT
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Responsible party
- Principal investigator, Bin Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Hao Wang, M.D., Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724709
- Sponsor's protocol ID
- 2016-096
- Status last verified
- Aug 2016
- First submitted
- 21 Mar 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 26320167Calleja 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.
PubMed 23233743Chambers 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.
PubMed 26977308Hahn 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.
PubMed 25772834Zhang 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.
PubMed 31297671
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi-automatic assessMent of Aortic Roots by Three-dimensional transoEsophageal echocaRdiography (SMARTER)
- ClinicalTrials.gov ID
- NCT02724709
- Acronym / sponsor ID
- 2016-096
- Conditions
- Aortic Valve Disease
- Keywords
- Automatic Data Processing, Three-Dimensional Echocardiography, Aortic Valve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- both transesophageal echocardiography (TEE) and computed tomographic (CT) are referred by cardiologists
- apparent normal aortic valve and root structure
- written consent
Key exclusion criteria (4 listed)
- post-operation of aortic valve
- severe cardiomyopathy
- cardiac functional insufficiency (NYHA III or IV)
- contraindications for either TEE or cardiac CT angiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-dimensional transoesophageal echocardiographyThree-dimensional transoesophageal echocardiography, analysed by eSie valve software (Siemens) | Procedure or surgery | – |
| Computed tomographyComputed tomography, analysed by Synovia Workstation (Siemens) | Procedure or surgery | – |
Primary outcome
Accuracy
Time frame: Through study completion, an average of 1 month
Compare semi-automatic assessment of 3D TEE to CT measurement
2 secondary outcomes
Cost
Time frame: Through study completion, an average of 1 month
Labor time
Time frame: Through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Background: PubMed 26320167Garcia-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.
- Background: PubMed 23233743Calleja 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.
- Background: PubMed 26977308Chambers 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.
- Background: PubMed 25772834Hahn 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.
- Derived from this study: PubMed 31297671Zhang 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Wang, M.D. study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: Through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02724709, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.