Clinical trial Recruiting at 1 site Interventional

Assessing heart function in children with single-ventricle congenital heart disease

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

Run by Duke University · NCT05262907 · Data updated 2026-11-12

This study is testing a new 3D heart imaging technique to see if it can better measure heart size and function in children and young adults with a specific type of heart defect compared to the standard MRI method.

Quick facts

Study typeInterventional
SexAll
Enrollment100 (estimated)
SponsorDuke University
Academic / other
Locations1 site (Durham, North Carolina)
StatusRecruiting
StartedJuly 8, 2022
Main results expectedAugust 2027
Study endsAugust 2027
Registry record updatedOctober 23, 2025
Trial IDNCT05262907 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children and young adults with functional single ventricles who have had or are scheduled for a transthoracic echocardiogram or cardiac MRI.

Probably not a fit

Patients with congenital heart disease other than functional single ventricles or those unable to consent in English may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to validate a new 3D echocardiographic technique for measuring cardiac size and function in children and young adults with functional single ventricles. Current echocardiographic methods are limited by geometric assumptions and challenges in visualizing malformed hearts. The study will compare this new technique to the gold standard of cardiac MRI to determine its accuracy and effectiveness. Participants will include those who have undergone or are scheduled for a transthoracic echocardiogram or cardiac MRI.

Why it matters

Potential benefit: If successful, this study could lead to more accurate assessments of heart function in patients with single-ventricle congenital heart disease, improving clinical decision-making.

How similar studies have gone: While this approach is innovative, it builds on existing echocardiographic techniques, and similar studies have shown promise in improving cardiac assessments.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 it's running

  • Duke University
    Durham, North Carolina, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.