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NCT05262907NARecruiting

Ventripoint Single Ventricle Study

Duke University

Start Date

7/8/2022

Completion Date

8/1/2027

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 functional single ventricles, as well as the inability to visualize the entire heart at one time from a single imaging window, and higher heart rates degrading 3D imaging volume rates. 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, including a comparison to the gold standard of cardiac MRI.

Eligibility Criteria

Age Range: No minimum to No maximum

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.

Interventions

DEVICE

Transthoracic Echocardiogram or Cardiac MRI

DEVICE

Ventripoint Echocardiogram

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Conditions

Congenital Heart DiseaseSingle-ventricle

Locations

Duke University

Durham, North Carolina 27705

United States