Ventripoint Single Ventricle Study

Duke University

Status: Enrolling

Conditions: Single-ventricle; Congenital Heart Disease

Treatments: Device: Transthoracic Echocardiogram or Cardiac MRI; Device: Ventripoint Echocardiogram

Study type: Interventional

Funder types: Other

Identifiers

NCT05262907

Pro00108548

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Ventripoint 3D Echocardiogram

Experimental group

Description:

Ventripoint 3D Echo performed on subject to validate technology for use in single ventricle patients.

Treatment:

Device: Ventripoint Echocardiogram

Transthoracic Echocardiogram or Cardiac MRI

Active Comparator group

Description:

Non-invasive imaging of the heart to evaluate structure and function.

Treatment:

Device: Transthoracic Echocardiogram or Cardiac MRI