Recruiting

Echocardiographic Technique

Sponsor:

Duke University

Code:

NCT05262907

Conditions

Congenital Heart Disease

Single-ventricle

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Transthoracic Echocardiogram or Cardiac MRI

Ventripoint Echocardiogram

Study Details

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.

Conditions

Congenital Heart Disease

Single-ventricle

Study ID

NCT05262907

Start date

Jul 8, 2022

Status verified date

Oct, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Ventripoint 3D Echocardiogram

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

active comparator: Transthoracic Echocardiogram or Cardiac MRI

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

Interventions

Transthoracic Echocardiogram or Cardiac MRI

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

Ventripoint Echocardiogram

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

Primary outcome measure

  • Cardiac function of the right ventricle as measured by ejection fraction [ Time Frame: Day 1 ]
  • Cardiac function of the left ventricle as measured by ejection fraction [ Time Frame: Day 1 ]
  • Right ventricular dimension as measured by end diastolic volume [ Time Frame: Day 1 ]
  • Right ventricular dimension as measured by end systolic volume [ Time Frame: Day 1 ]
  • Left Ventricular Dimension as measured by end diastolic volume [ Time Frame: Day 1 ]
  • Left Ventricular Dimension as measured by end systolic volume [ Time Frame: Day 1 ]
  • Left Ventricular Dimension as measured by end diastolic diameter [ Time Frame: Day 1 ]
  • Left Ventricular Dimension as measured by end systolic diameter [ Time Frame: Day 1 ]
  • Right Ventricular Function as measured by tricuspid annular plane systolic excursion [ Time Frame: Day 1 ]
  • Right Ventricular Function as measured by myocardial performance index [ Time Frame: Day 1 ]
  • Left Ventricular Function as measured by myocardial performance index [ Time Frame: Day 1 ]
  • Left Ventricular Function as measured by tissue doppler imaging [ Time Frame: Day 1 ]
  • Left ventricular function as measured by shortening fraction [ Time Frame: Day 1 ]
  • Presence of ventricular dysfunction as measured by strain [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Joan Wilson

999999999joan.wilson@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Piers Barker, MD

piers.barker@duke.edu

More Information

Sponsor

Duke University

Last update posted

Oct 23, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-10-23.