NCT05262907

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jul 2022Aug 2027

First Submitted

Initial submission to the registry

February 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

5.1 years

First QC Date

February 21, 2022

Last Update Submit

October 21, 2025

Conditions

Congenital Heart DiseaseSingle-ventricle

Outcome Measures

Primary Outcomes (14)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Day 1

  • Left Ventricular Function as measured by tissue doppler imaging

    Tissue Doppler Imaging (TDI) a measurement of the velocity of myocardial motion.

    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.

    Day 1

  • Presence of ventricular dysfunction as measured by strain

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

    Day 1

Study Arms (2)

Ventripoint 3D Echocardiogram

EXPERIMENTAL

Ventripoint 3D Echo performed on subject to validate technology for use in single ventricle patients.

Device: Ventripoint Echocardiogram

Transthoracic Echocardiogram or Cardiac MRI

ACTIVE COMPARATOR

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

Device: Transthoracic Echocardiogram or Cardiac MRI

Interventions

Transthoracic Echocardiogram or Cardiac MRIDEVICE

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

Transthoracic Echocardiogram or Cardiac MRI
Ventripoint EchocardiogramDEVICE

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

Ventripoint 3D Echocardiogram

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Heart Defects, CongenitalUniventricular Heart

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Piers Barker, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan Wilson

CONTACT

999999999joan.wilson@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 2, 2022

Study Start

July 8, 2022

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

October 23, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)