NCT05262907 · Duke University
Ventripoint Single Ventricle Study
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Transthoracic Echocardiogram or Cardiac MRI
Non-invasive imaging of the heart to evaluate structure and function.
DEVICE
Ventripoint Echocardiogram
Non-invasive ultrasound of the heart to evaluate structure and function through 3D imaging.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 23, 2025 · Source of record for eligibility and locations