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NCT Number: NCT05262907

Ventripoint Single Ventricle Study

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Single-ventricle Univentricular Heart

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Piers Barker, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transthoracic Echocardiogram or Cardiac MRI

Device

Non-invasive imaging of the heart to evaluate structure and function.

Ventripoint Echocardiogram

Device

Non-invasive ultrasound of the heart to evaluate structure and function through 3D imaging.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. Presence of ventricular dysfunction as measured by strain

    Time frame: Day 1

    Strain is a measure of deformity in the muscle of the ventricle.

Study contacts

Contact information is provided by the study sponsor or research team.

Joan Wilson

CONTACT

[email protected]

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Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Assessment of Ventricular Volumes and Function in Single Ventricle Patients Using Ventripoint 3D Echocardiography

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2022
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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