Status:
RECRUITING
Ventripoint Single Ventricle Study
Lead Sponsor:
Duke University
Conditions:
Congenital Heart Disease
Single-ventricle
Eligibility:
All Genders
Phase:
NA
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.
Detailed Description
The accuracy of current echocardiographic techniques for measuring ventricular size and function are limited by geometric assumptions, which are particularly problematic in malformed hearts or functio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05262907
Start Date
July 8 2022
End Date
August 1 2027
Last Update
October 23 2025
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27705