Ventripoint Single Ventricle Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-08

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Congenital Heart Disease Single-ventricle

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ventripoint 3D Echocardiogram

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

Group Type EXPERIMENTAL

Ventripoint Echocardiogram

Intervention Type DEVICE

Non-invasive ultrasound of the heart to evaluate structure and function through 3D imaging.

Transthoracic Echocardiogram or Cardiac MRI

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

Group Type ACTIVE_COMPARATOR

Transthoracic Echocardiogram or Cardiac MRI

Intervention Type DEVICE

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

Interventions

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Transthoracic Echocardiogram or Cardiac MRI

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

Intervention Type DEVICE

Ventripoint Echocardiogram

Non-invasive ultrasound of the heart to evaluate structure and function through 3D imaging.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No