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 type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | July 8, 2022 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | October 23, 2025 |
| Trial ID | NCT05262907 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
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Duke University
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Piers Barker, MD — Duke University
- Study coordinator: Joan Wilson
- Email: joan.wilson@duke.edu
- Phone: 999999999
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.