Congenital Heart DiseaseNCT05262907
Ventripoint Single Ventricle Study
A study testing Transthoracic Echocardiogram or Cardiac MRI and Ventripoint Echocardiogram in people with Congenital Heart Disease and Single-ventricle, run by Duke University at 1 site in United States.
Trial summary
This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease, Single-ventricle
- What is being tested?
- Transthoracic Echocardiogram or Cardiac MRI and Ventripoint Echocardiogram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2022to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with functional single ventricles will be included, regardless of age or surgical palliation stage, who have had or are having a clinically ordered transthoracic echocardiogram and/or cardiac MRI.
Who cannot join
- Patients with congenital heart disease other than functional single ventricles, patients with single ventricle physiology (but not single ventricle anatomy) following a biventricular conversion pathway, or patients unable to understand or consent in English will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27705
Piers Barker, MD, piers.barker@duke.edu
About this study
Official title: Assessment of Ventricular Volumes and Function in Single Ventricle Patients Using Ventripoint 3D Echocardiography
This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles.
Read the detailed description
The accuracy of current echocardiographic techniques for measuring ventricular size and function are limited by geometric assumptions, which are particularly problematic in malformed hearts or functional single ventricles, as well as the inability to visualize the entire heart at one time from a single imaging window, and higher heart rates degrading 3D imaging volume rates. This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles, including a comparison to the gold standard of cardiac MRI.
- Conditions
- Congenital Heart Disease, Single-ventricle
- Being tested
- Transthoracic Echocardiogram or Cardiac MRI, Ventripoint Echocardiogram
- Medical subject headings
- Heart Defects, Congenital, Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic Echocardiogram or Cardiac MRIDevice
Non-invasive imaging of the heart to evaluate structure and function.
Ventripoint EchocardiogramDevice
Non-invasive ultrasound of the heart to evaluate structure and function through 3D imaging.
| Study group | Role | What they receive |
|---|---|---|
| Ventripoint 3D Echocardiogram | Experimental | Ventripoint 3D Echo performed on subject to validate technology for use in single ventricle patients. Receives: Device: Ventripoint Echocardiogram |
| Transthoracic Echocardiogram or Cardiac MRI | Active comparator | Non-invasive imaging of the heart to evaluate structure and function. Receives: Device: Transthoracic Echocardiogram or Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac function of the right ventricle as measured by ejection fraction
Ejection Fraction (EF) is a measurement of the percentage of blood leaving your heart each time it squeezes (contracts)with each heart beat.
Measured: Day 1
Cardiac function of the left ventricle as measured by ejection fraction
Ejection Fraction (EF) is a measurement of the percentage of blood leaving your heart each time it squeezes (contracts)with each heart beat.
Measured: Day 1
Right ventricular dimension as measured by end diastolic volume
End Diastolic Volume (EDV) is the volume of blood in a ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole.
Measured: Day 1
Right ventricular dimension as measured by end systolic volume
End Systolic Volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.
Measured: Day 1
Left Ventricular Dimension as measured by end diastolic volume
End Diastolic Volume (EDV) is the volume of blood in a ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole.
Measured: Day 1
Left Ventricular Dimension as measured by end systolic volume
End Systolic Volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.
Measured: Day 1
Left Ventricular Dimension as measured by end diastolic diameter
End Diastolic Diameter (EDD) is the diameter across the left ventricle of the heart at the end of diastole, that is, when the heart muscle is maximally relaxed, and usually corresponds to its largest diameter.
Measured: Day 1
Left Ventricular Dimension as measured by end systolic diameter
End Systolic Diameter (ESD) is the diameter across the left ventricle of the heart at the end of systole, that is, when the heart muscle is maximally contracted, and usually corresponds to its smallest diameter.
Measured: Day 1
Right Ventricular Function as measured by tricuspid annular plane systolic excursion
Tricuspid Annular Plane Systolic Excursion (TAPSE) is a measurement of the decent of the right ventricular base towards a relatively fixed apex.
Measured: Day 1
Right Ventricular Function as measured by myocardial performance index
RV Myocardial Performance Index (MPI) is a measurement that incorporates tricuspid valve closure to opening time and right ventricular ejection time to evaluate efficiency of the ventricle.
Measured: Day 1
Left Ventricular Function as measured by myocardial performance index
LV Myocardial Performance Index (MPI) is a measurement that incorporates mitral valve closure to opening time and left ventricular ejection time to evaluate efficiency of the ventricle.
Measured: Day 1
Left Ventricular Function as measured by tissue doppler imaging
Tissue Doppler Imaging (TDI) a measurement of the velocity of myocardial motion.
Measured: Day 1
Left ventricular function as measured by shortening fraction
Shortening fraction(SF) is a measurement of the percentage of change in left ventricular diameter during systole.
Measured: Day 1
Presence of ventricular dysfunction as measured by strain
Strain is a measure of deformity in the muscle of the ventricle.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start8 Jul 2022
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piers Barker, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262907
- Sponsor's protocol ID
- Pro00108548
- Status last verified
- Oct 2025
- First submitted
- 21 Feb 2022
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Ventricular Volumes and Function in Single Ventricle Patients Using Ventripoint 3D Echocardiography
- ClinicalTrials.gov ID
- NCT05262907
- Acronym / sponsor ID
- Pro00108548
- Conditions
- Congenital Heart Disease, Single-ventricle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 2 Mar 2022 (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.
This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles.
Detailed description
The accuracy of current echocardiographic techniques for measuring ventricular size and function are limited by geometric assumptions, which are particularly problematic in malformed hearts or functional single ventricles, as well as the inability to visualize the entire heart at one time from a single imaging window, and higher heart rates degrading 3D imaging volume rates. This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles, including a comparison to the gold standard of cardiac MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventripoint 3D Echocardiogram | Experimental | Device: Ventripoint EchocardiogramVentripoint 3D Echo performed on subject to validate technology for use in single ventricle patients. |
| Transthoracic Echocardiogram or Cardiac MRI | Active comparator | Device: Transthoracic Echocardiogram or Cardiac MRINon-invasive imaging of the heart to evaluate structure and function. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with functional single ventricles will be included, regardless of age or surgical palliation stage, who have had or are having a clinically ordered transthoracic echocardiogram and/or cardiac MRI.
Key exclusion criteria (1 listed)
- Patients with congenital heart disease other than functional single ventricles, patients with single ventricle physiology (but not single ventricle anatomy) following a biventricular conversion pathway, or patients unable to understand or consent in English will be excluded.
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 |
|---|---|---|
| Transthoracic Echocardiogram or Cardiac MRINon-invasive imaging of the heart to evaluate structure and function. | Device | Transthoracic Echocardiogram or Cardiac MRI |
| Ventripoint EchocardiogramNon-invasive ultrasound of the heart to evaluate structure and function through 3D imaging. | Device | Ventripoint 3D Echocardiogram |
Primary outcome
Cardiac function of the right ventricle as measured by ejection fraction
Time frame: Day 1
Ejection Fraction (EF) is a measurement of the percentage of blood leaving your heart each time it squeezes (contracts)with each heart beat.
Cardiac function of the left ventricle as measured by ejection fraction
Time frame: Day 1
Ejection Fraction (EF) is a measurement of the percentage of blood leaving your heart each time it squeezes (contracts)with each heart beat.
Right ventricular dimension as measured by end diastolic volume
Time frame: Day 1
End Diastolic Volume (EDV) is the volume of blood in a ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole.
Right ventricular dimension as measured by end systolic volume
Time frame: Day 1
End Systolic Volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.
Left Ventricular Dimension as measured by end diastolic volume
Time frame: Day 1
End Diastolic Volume (EDV) is the volume of blood in a ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole.
Left Ventricular Dimension as measured by end systolic volume
Time frame: Day 1
End Systolic Volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.
Left Ventricular Dimension as measured by end diastolic diameter
Time frame: Day 1
End Diastolic Diameter (EDD) is the diameter across the left ventricle of the heart at the end of diastole, that is, when the heart muscle is maximally relaxed, and usually corresponds to its largest diameter.
Left Ventricular Dimension as measured by end systolic diameter
Time frame: Day 1
End Systolic Diameter (ESD) is the diameter across the left ventricle of the heart at the end of systole, that is, when the heart muscle is maximally contracted, and usually corresponds to its smallest diameter.
Right Ventricular Function as measured by tricuspid annular plane systolic excursion
Time frame: Day 1
Tricuspid Annular Plane Systolic Excursion (TAPSE) is a measurement of the decent of the right ventricular base towards a relatively fixed apex.
Right Ventricular Function as measured by myocardial performance index
Time frame: Day 1
RV Myocardial Performance Index (MPI) is a measurement that incorporates tricuspid valve closure to opening time and right ventricular ejection time to evaluate efficiency of the ventricle.
Left Ventricular Function as measured by myocardial performance index
Time frame: Day 1
LV Myocardial Performance Index (MPI) is a measurement that incorporates mitral valve closure to opening time and left ventricular ejection time to evaluate efficiency of the ventricle.
Left Ventricular Function as measured by tissue doppler imaging
Time frame: Day 1
Tissue Doppler Imaging (TDI) a measurement of the velocity of myocardial motion.
Left ventricular function as measured by shortening fraction
Time frame: Day 1
Shortening fraction(SF) is a measurement of the percentage of change in left ventricular diameter during systole.
Presence of ventricular dysfunction as measured by strain
Time frame: Day 1
Strain is a measure of deformity in the muscle of the ventricle.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Piers Barker, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic Echocardiogram or Cardiac MRI and Ventripoint Echocardiogram in people with Congenital Heart Disease and Single-ventricle, run by Duke University 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: looking for participants now, as of the sponsor's last update on 23 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joan Wilson (999999999, joan.wilson@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac function of the right ventricle as measured by ejection fraction (time frame: Day 1). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2025; AzTrials last refreshed its copy on 29 Oct 2026.