Assessing heart function in children with single-ventricle congenital heart disease
Assessment of Ventricular Volumes and Function in Single Ventricle Patients Using Ventripoint 3D Echocardiography
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05262907 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is innovative, it builds on existing echocardiographic techniques, and similar studies have shown promise in improving cardiac assessments.
Eligibility criteria
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 this trial is running
Durham, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.