Ventricular FunctionNCT04099810
Assessment of Right Ventricular Volume in Pediatric Patients
A study testing three-dimensional echocardiography in people with Ventricular Function, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Most publication are basing RV volumes on images acquired from the apical window. However, some data have called the practice of basing these images on apical window into question. Moreover, despite our best efforts, we have been unable, in our laboratory to reliably visualize RV outflow from the apical view. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Ventricular Function
- What is being tested?
- three-dimensional echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Dec 2023
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients<18y scheduled to undergo CMR for clinical reasons.
Who cannot join
- Patients >18y
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Assessment of Right Ventricular Volume in Pediatric Patients - Is Apical or Subcostal Window More Accurate?
Most publication are basing RV volumes on images acquired from the apical window. However, some data have called the practice of basing these images on apical window into question. Moreover, despite our best efforts, we have been unable, in our laboratory to reliably visualize RV outflow from the apical view. Therefore, with an identified group of trained sonographers, we plan to conduct a head-to-head comparison of RV volumes acquired from these two windows (apical and subcostal), with comparison to gold-standard CMR.
Read the detailed description
The knowledge of right ventricular (RV) volumes is important from a clinical prospective. Traditionally, these volumes have been measured by cardiac magnetic resonance (CMR) because of its accuracy, reproducibility, and freedom from geometric assumptions. More and more, however, 3D echo has been used for assessment of ventricular volumes, first for left ventricle, now increasingly for RV. Most publication are basing RV volumes on images acquired from the apical window. However, some data have called the practice of basing these images on apical window into question. Moreover, despite our best efforts, we have been unable, in our laboratory to reliably visualize RV outflow from the apical view. An alternative view that can be used for RV 3D volume acquisition (first pioneered at BCH) is the subcostal view. Therefore, we plan to conduct a head-to-head comparison of RV volumes acquired from these two windows (apical and subcostal), with comparison to gold-standard CMR.
Hypothesis: RVEDV measured by the subcostal window is more accurate than RV volume measured in the apical window in a cohort of pediatric patients.
Analytic plan: Echocardiograms will be performed on the same day as the CMR, and will be performed by a group of sonographers trained in 3D volume acquisition. Descriptive statistics will include mean and median absolute % error and coefficients of variation. A paired t-test will be used to compare raw differences in %error for apical vs. subcostal window measurements. If the %error is highly skewed, a Wilcoxon signed-rank test will be used or the %error values will be log-transformed before application of the paired t-test (if no zero %error values exist). Linear regression will be used to estimate the window-differences in %error or log(%error) controlling for age and/or sedation status. Assessments of feasibility for both windows will be performed as described by Renella et al; and reproducibility of measurements made with echo vs. CMR will be also be graphically assessed using Bland-Altman plots of the raw measurements for data derived from each window. As a secondary (stratified) analysis, we anticipate dividing the cohort into 2 groups of 25 patients each (25 < 10y; 25 > 10y). Patients under 10y will typically be under anesthesia. Exploratory analyses will investigate subgroup differences defined by demographic/ surgical variables with respect to the magnitude of the difference between the 2 techniques. Of note the analyses performed above will also be performed for LV (in addition to RV) as a secondary analysis (with comparison of LV-specific vs. non-LV specific software, as appropriate).
Sample size/Power: funding is provided for 50 patients and this will be our target sample size. The analysis will be paired, to compare the %error (echo relative to MRI) measurements from apical vs. subcostal windows). To detect a 0.5 SD difference in apical vs. subcostal windows %error with 85% power, 38 subjects with echo \& MRI are required. If the comparisons are performed stratified by age (25 subjects per age group), there is 80% power to detect a 0.58 SD difference in apical vs. subcostal windows %error.
Limitations: CMR, while considered a gold-standard, has a certain amount of intrinsic variability in volume measurement. Moreover, a statistically significant difference may not necessary be a clinically important difference. Patients will not have echo and CMR performed at the exact same time.
- Conditions
- Ventricular Function
- Being tested
- three-dimensional echocardiography
- Keywords
- three-dimensional echocardiography, right ventricular volumes, cardiac magnetic resonance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
three-dimensional echocardiographyDiagnostic test
A focused echocardiographic exam will be performed. In details will be acquired:
- high frame rate imaging clips acquired in a static position with attention to endocardial border optimization, minimum of 3 beats recorded with 'Acquire 2', of: a. Left ventricle 2c/3c/4c; b. left ventricle SAB, SAX-M, SAX-A; c. right ventricular focused apical view.
- Full volumes: a. 3d left ventricular apical acquisition; b. right ventricular apical acquisition; c. subcostal right ventricular acquisition.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing Cardiac MRI | Other | Patients scheduled to undergo cardiac magnetic resonance for clinical reason will be asked if they are willing to undergo additional non invasive testing (three-dimensional echocardiography) which will take about 15-20 minutes Receives: Diagnostic Test: three-dimensional echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute %error in end diastolic volume measurements
Mean absolute %error in end diastolic volume measurements (apical and subcostal windows) (echocardiographic vs. gold-standard CMR); echocardiographic right ventricular (RV) volumes measured using RV-specific software
Measured: 0 days
Secondary outcomes (2)
Mean absolute %error in right ventricular end systolic volume (RVESV) / right ventricular ejection fraction (RVEF)
Mean absolute %error in right ventricular end systolic volume (RVESV) / right ventricular ejection fraction (RVEF) (apical and subcostal windows) (echocardiographic vs. gold-standard cardiac MRI) for RV volumes measured using RV-specific software
Measured: 0 days
Mean absolute %error in RVEDV/RVESV/RVEF (subcostal window)
Mean absolute %error in RVEDV/RVESV/RVEF (subcostal window) for RV volumes measured with RV nonspecific software vs. RV specific software
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Oct 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Ventricular FunctionStudies of the same condition, open and under way.
- More trials run by Boston Children's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Harrild, Boston Children's Hospital
- Investigators
- David M Harrild, MD, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099810
- Sponsor's protocol ID
- IRB-P00033035
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2019
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share data has been considered until now.
Publications
Kutty S, Zhou J, Gauvreau K, Trincado C, Powell AJ, Geva T. Regional dysfunction of the right ventricular outflow tract reduces the accuracy of Doppler tissue imaging assessment of global right ventricular systolic function in patients with repaired tetralogy of Fallot. J Am Soc Echocardiogr. 2011 Jun;24(6):637-43. doi: 10.1016/j.echo.2011.01.020. Epub 2011 Mar 9.
PubMed 21392939Geva T. Repaired tetralogy of Fallot: the roles of cardiovascular magnetic resonance in evaluating pathophysiology and for pulmonary valve replacement decision support. J Cardiovasc Magn Reson. 2011 Jan 20;13(1):9. doi: 10.1186/1532-429X-13-9.
PubMed 21251297Williams RG, Pearson GD, Barst RJ, Child JS, del Nido P, Gersony WM, Kuehl KS, Landzberg MJ, Myerson M, Neish SR, Sahn DJ, Verstappen A, Warnes CA, Webb CL; National Heart, Lung, and Blood Institute Working Group on research in adult congenital heart disease. Report of the National Heart, Lung, and Blood Institute Working Group on research in adult congenital heart disease. J Am Coll Cardiol. 2006 Feb 21;47(4):701-7. doi: 10.1016/j.jacc.2005.08.074. Epub 2006 Jan 26.
PubMed 16487831Oosterhof T, van Straten A, Vliegen HW, Meijboom FJ, van Dijk AP, Spijkerboer AM, Bouma BJ, Zwinderman AH, Hazekamp MG, de Roos A, Mulder BJ. Preoperative thresholds for pulmonary valve replacement in patients with corrected tetralogy of Fallot using cardiovascular magnetic resonance. Circulation. 2007 Jul 31;116(5):545-51. doi: 10.1161/CIRCULATIONAHA.106.659664. Epub 2007 Jul 9.
PubMed 17620511Knauth AL, Gauvreau K, Powell AJ, Landzberg MJ, Walsh EP, Lock JE, del Nido PJ, Geva T. Ventricular size and function assessed by cardiac MRI predict major adverse clinical outcomes late after tetralogy of Fallot repair. Heart. 2008 Feb;94(2):211-6. doi: 10.1136/hrt.2006.104745. Epub 2006 Nov 29.
PubMed 17135219Pennell DJ, Sechtem UP, Higgins CB, Manning WJ, Pohost GM, Rademakers FE, van Rossum AC, Shaw LJ, Yucel EK; Society for Cardiovascular Magnetic Resonance; Working Group on Cardiovascular Magnetic Resonance of the European Society of Cardiology. Clinical indications for cardiovascular magnetic resonance (CMR): Consensus Panel report. Eur Heart J. 2004 Nov;25(21):1940-65. doi: 10.1016/j.ehj.2004.06.040. No abstract available.
PubMed 15522474Kochav J, Simprini L, Weinsaft JW. Imaging of the right heart--CT and CMR. Echocardiography. 2015 Jan;32 Suppl 1:S53-68. doi: 10.1111/echo.12212. Epub 2014 Sep 19.
PubMed 25244072Monaghan MJ. Role of real time 3D echocardiography in evaluating the left ventricle. Heart. 2006 Jan;92(1):131-6. doi: 10.1136/hrt.2004.058388. No abstract available.
PubMed 16365369Aune E, Baekkevar M, Rodevand O, Otterstad JE. Reference values for left ventricular volumes with real-time 3-dimensional echocardiography. Scand Cardiovasc J. 2010 Feb;44(1):24-30. doi: 10.3109/14017430903114446.
PubMed 19626561Chahal NS, Lim TK, Jain P, Chambers JC, Kooner JS, Senior R. Population-based reference values for 3D echocardiographic LV volumes and ejection fraction. JACC Cardiovasc Imaging. 2012 Dec;5(12):1191-7. doi: 10.1016/j.jcmg.2012.07.014.
PubMed 23236967Muraru D, Badano LP, Peluso D, Dal Bianco L, Casablanca S, Kocabay G, Zoppellaro G, Iliceto S. Comprehensive analysis of left ventricular geometry and function by three-dimensional echocardiography in healthy adults. J Am Soc Echocardiogr. 2013 Jun;26(6):618-28. doi: 10.1016/j.echo.2013.03.014. Epub 2013 Apr 20.
PubMed 23611056Medvedofsky D, Addetia K, Patel AR, Sedlmeier A, Baumann R, Mor-Avi V, Lang RM. Novel Approach to Three-Dimensional Echocardiographic Quantification of Right Ventricular Volumes and Function from Focused Views. J Am Soc Echocardiogr. 2015 Oct;28(10):1222-31. doi: 10.1016/j.echo.2015.06.013. Epub 2015 Aug 1.
PubMed 26237996Ostenfeld E, Flachskampf FA. Assessment of right ventricular volumes and ejection fraction by echocardiography: from geometric approximations to realistic shapes. Echo Res Pract. 2015 Mar 1;2(1):R1-R11. doi: 10.1530/ERP-14-0077. Epub 2015 Jan 7.
PubMed 26693327Laser KT, Karabiyik A, Korperich H, Horst JP, Barth P, Kececioglu D, Burchert W, DallaPozza R, Herberg U. Validation and Reference Values for Three-Dimensional Echocardiographic Right Ventricular Volumetry in Children: A Multicenter Study. J Am Soc Echocardiogr. 2018 Sep;31(9):1050-1063. doi: 10.1016/j.echo.2018.03.010. Epub 2018 Jun 19.
PubMed 29908725Renella P, Marx GR, Zhou J, Gauvreau K, Geva T. Feasibility and reproducibility of three-dimensional echocardiographic assessment of right ventricular size and function in pediatric patients. J Am Soc Echocardiogr. 2014 Aug;27(8):903-10. doi: 10.1016/j.echo.2014.04.008. Epub 2014 May 14.
PubMed 24836600
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Right Ventricular Volume in Pediatric Patients - Is Apical or Subcostal Window More Accurate?
- ClinicalTrials.gov ID
- NCT04099810
- Acronym / sponsor ID
- IRB-P00033035
- Conditions
- Ventricular Function
- Keywords
- three-dimensional echocardiography, right ventricular volumes, cardiac magnetic resonance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Sep 2019 (actual)
- 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.
Most publication are basing RV volumes on images acquired from the apical window. However, some data have called the practice of basing these images on apical window into question. Moreover, despite our best efforts, we have been unable, in our laboratory to reliably visualize RV outflow from the apical view. Therefore, with an identified group of trained sonographers, we plan to conduct a head-to-head comparison of RV volumes acquired from these two windows (apical and subcostal), with comparison to gold-standard CMR.
Detailed description
The knowledge of right ventricular (RV) volumes is important from a clinical prospective. Traditionally, these volumes have been measured by cardiac magnetic resonance (CMR) because of its accuracy, reproducibility, and freedom from geometric assumptions. More and more, however, 3D echo has been used for assessment of ventricular volumes, first for left ventricle, now increasingly for RV. Most publication are basing RV volumes on images acquired from the apical window. However, some data have called the practice of basing these images on apical window into question. Moreover, despite our best efforts, we have been unable, in our laboratory to reliably visualize RV outflow from the apical view. An alternative view that can be used for RV 3D volume acquisition (first pioneered at BCH) is the subcostal view. Therefore, we plan to conduct a head-to-head comparison of RV volumes acquired from these two windows (apical and subcostal), with comparison to gold-standard CMR.
Hypothesis: RVEDV measured by the subcostal window is more accurate than RV volume measured in the apical window in a cohort of pediatric patients.
Analytic plan: Echocardiograms will be performed on the same day as the CMR, and will be performed by a group of sonographers trained in 3D volume acquisition. Descriptive statistics will include mean and median absolute % error and coefficients of variation. A paired t-test will be used to compare raw differences in %error for apical vs. subcostal window measurements. If the %error is highly skewed, a Wilcoxon signed-rank test will be used or the %error values will be log-transformed before application of the paired t-test (if no zero %error values exist). Linear regression will be used to estimate the window-differences in %error or log(%error) controlling for age and/or sedation status. Assessments of feasibility for both windows will be performed as described by Renella et al; and reproducibility of measurements made with echo vs. CMR will be also be graphically assessed using Bland-Altman plots of the raw measurements for data derived from each window. As a secondary (stratified) analysis, we anticipate dividing the cohort into 2 groups of 25 patients each (25 < 10y; 25 > 10y). Patients under 10y will typically be under anesthesia. Exploratory analyses will investigate subgroup differences defined by demographic/ surgical variables with respect to the magnitude of the difference between the 2 techniques. Of note the analyses performed above will also be performed for LV (in addition to RV) as a secondary analysis (with comparison of LV-specific vs. non-LV specific software, as appropriate).
Sample size/Power: funding is provided for 50 patients and this will be our target sample size. The analysis will be paired, to compare the %error (echo relative to MRI) measurements from apical vs. subcostal windows). To detect a 0.5 SD difference in apical vs. subcostal windows %error with 85% power, 38 subjects with echo \& MRI are required. If the comparisons are performed stratified by age (25 subjects per age group), there is 80% power to detect a 0.58 SD difference in apical vs. subcostal windows %error.
Limitations: CMR, while considered a gold-standard, has a certain amount of intrinsic variability in volume measurement. Moreover, a statistically significant difference may not necessary be a clinically important difference. Patients will not have echo and CMR performed at the exact same time.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing Cardiac MRI | Other | Diagnostic Test: three-dimensional echocardiographyPatients scheduled to undergo cardiac magnetic resonance for clinical reason will be asked if they are willing to undergo additional non invasive testing (three-dimensional echocardiography) which will take about 15-20 minutes |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients<18y scheduled to undergo CMR for clinical reasons.
Key exclusion criteria (1 listed)
- Patients >18y
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 echocardiographyA focused echocardiographic exam will be performed. In details will be acquired: * high frame rate imaging clips acquired in a static position with attention to endocardial border optimization, minimum of 3 beats recorded with 'Acquire 2', of: a. Left ventricle 2c/3c/4c; b. left ventricle SAB, SAX-M, SAX-A; c. right ventricular focused apical view. * Full volumes: a. 3d left ventricular apical acquisition; b. right ventricular apical acquisition; c. subcostal right ventricular acquisition. | Diagnostic test | Patients undergoing Cardiac MRI |
Primary outcome
Mean absolute %error in end diastolic volume measurements
Time frame: 0 days
Mean absolute %error in end diastolic volume measurements (apical and subcostal windows) (echocardiographic vs. gold-standard CMR); echocardiographic right ventricular (RV) volumes measured using RV-specific software
2 secondary outcomes
Mean absolute %error in right ventricular end systolic volume (RVESV) / right ventricular ejection fraction (RVEF)
Time frame: 0 days
Mean absolute %error in RVEDV/RVESV/RVEF (subcostal window)
Time frame: 0 days
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 4 May 2026.
- Background: PubMed 21392939Kutty S, Zhou J, Gauvreau K, Trincado C, Powell AJ, Geva T. Regional dysfunction of the right ventricular outflow tract reduces the accuracy of Doppler tissue imaging assessment of global right ventricular systolic function in patients with repaired tetralogy of Fallot. J Am Soc Echocardiogr. 2011 Jun;24(6):637-43. doi: 10.1016/j.echo.2011.01.020. Epub 2011 Mar 9.
- Background: PubMed 21251297Geva T. Repaired tetralogy of Fallot: the roles of cardiovascular magnetic resonance in evaluating pathophysiology and for pulmonary valve replacement decision support. J Cardiovasc Magn Reson. 2011 Jan 20;13(1):9. doi: 10.1186/1532-429X-13-9.
- Background: PubMed 16487831Williams RG, Pearson GD, Barst RJ, Child JS, del Nido P, Gersony WM, Kuehl KS, Landzberg MJ, Myerson M, Neish SR, Sahn DJ, Verstappen A, Warnes CA, Webb CL; National Heart, Lung, and Blood Institute Working Group on research in adult congenital heart disease. Report of the National Heart, Lung, and Blood Institute Working Group on research in adult congenital heart disease. J Am Coll Cardiol. 2006 Feb 21;47(4):701-7. doi: 10.1016/j.jacc.2005.08.074. Epub 2006 Jan 26.
- Background: PubMed 17620511Oosterhof T, van Straten A, Vliegen HW, Meijboom FJ, van Dijk AP, Spijkerboer AM, Bouma BJ, Zwinderman AH, Hazekamp MG, de Roos A, Mulder BJ. Preoperative thresholds for pulmonary valve replacement in patients with corrected tetralogy of Fallot using cardiovascular magnetic resonance. Circulation. 2007 Jul 31;116(5):545-51. doi: 10.1161/CIRCULATIONAHA.106.659664. Epub 2007 Jul 9.
- Background: PubMed 17135219Knauth AL, Gauvreau K, Powell AJ, Landzberg MJ, Walsh EP, Lock JE, del Nido PJ, Geva T. Ventricular size and function assessed by cardiac MRI predict major adverse clinical outcomes late after tetralogy of Fallot repair. Heart. 2008 Feb;94(2):211-6. doi: 10.1136/hrt.2006.104745. Epub 2006 Nov 29.
- Background: PubMed 15522474Pennell DJ, Sechtem UP, Higgins CB, Manning WJ, Pohost GM, Rademakers FE, van Rossum AC, Shaw LJ, Yucel EK; Society for Cardiovascular Magnetic Resonance; Working Group on Cardiovascular Magnetic Resonance of the European Society of Cardiology. Clinical indications for cardiovascular magnetic resonance (CMR): Consensus Panel report. Eur Heart J. 2004 Nov;25(21):1940-65. doi: 10.1016/j.ehj.2004.06.040. No abstract available.
- Background: PubMed 25244072Kochav J, Simprini L, Weinsaft JW. Imaging of the right heart--CT and CMR. Echocardiography. 2015 Jan;32 Suppl 1:S53-68. doi: 10.1111/echo.12212. Epub 2014 Sep 19.
- Background: PubMed 16365369Monaghan MJ. Role of real time 3D echocardiography in evaluating the left ventricle. Heart. 2006 Jan;92(1):131-6. doi: 10.1136/hrt.2004.058388. No abstract available.
- Background: PubMed 19626561Aune E, Baekkevar M, Rodevand O, Otterstad JE. Reference values for left ventricular volumes with real-time 3-dimensional echocardiography. Scand Cardiovasc J. 2010 Feb;44(1):24-30. doi: 10.3109/14017430903114446.
- Background: PubMed 23236967Chahal NS, Lim TK, Jain P, Chambers JC, Kooner JS, Senior R. Population-based reference values for 3D echocardiographic LV volumes and ejection fraction. JACC Cardiovasc Imaging. 2012 Dec;5(12):1191-7. doi: 10.1016/j.jcmg.2012.07.014.
- Background: PubMed 23611056Muraru D, Badano LP, Peluso D, Dal Bianco L, Casablanca S, Kocabay G, Zoppellaro G, Iliceto S. Comprehensive analysis of left ventricular geometry and function by three-dimensional echocardiography in healthy adults. J Am Soc Echocardiogr. 2013 Jun;26(6):618-28. doi: 10.1016/j.echo.2013.03.014. Epub 2013 Apr 20.
- Background: PubMed 26237996Medvedofsky D, Addetia K, Patel AR, Sedlmeier A, Baumann R, Mor-Avi V, Lang RM. Novel Approach to Three-Dimensional Echocardiographic Quantification of Right Ventricular Volumes and Function from Focused Views. J Am Soc Echocardiogr. 2015 Oct;28(10):1222-31. doi: 10.1016/j.echo.2015.06.013. Epub 2015 Aug 1.
- Individual participant dataSharing planned: No. No plan to share data has been considered until now.
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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.
David M Harrild, MD, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing three-dimensional echocardiography in people with Ventricular Function, run by Boston Children's Hospital at 1 site in United States.
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 1 inclusion and 1 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 4 May 2026. 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 United States. 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?
Mean absolute %error in end diastolic volume measurements (time frame: 0 days). 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 NCT04099810, which also lists 15 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 4 May 2026.