Ventripoint Single Ventricle Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transthoracic Echocardiogram or Cardiac MRI, Ventripoint Echocardiogram.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease, Single-ventricle. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of Ventricular Volumes and Function in Single Ventricle Patients Using Ventripoint 3D Echocardiography
Overview
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.
Interventions
- Device Transthoracic Echocardiogram or Cardiac MRI
Non-invasive imaging of the heart to evaluate structure and function. - Device Ventripoint Echocardiogram
Non-invasive ultrasound of the heart to evaluate structure and function through 3D imaging.
Primary outcome measures
- Cardiac function of the right ventricle as measured by ejection fraction [Time frame: Day 1]
- Cardiac function of the left ventricle as measured by ejection fraction [Time frame: Day 1]
- Right ventricular dimension as measured by end diastolic volume [Time frame: Day 1]
- Right ventricular dimension as measured by end systolic volume [Time frame: Day 1]
- Left Ventricular Dimension as measured by end diastolic volume [Time frame: Day 1]
- Left Ventricular Dimension as measured by end systolic volume [Time frame: Day 1]
- Left Ventricular Dimension as measured by end diastolic diameter [Time frame: Day 1]
- Left Ventricular Dimension as measured by end systolic diameter [Time frame: Day 1]
- Right Ventricular Function as measured by tricuspid annular plane systolic excursion [Time frame: Day 1]
- Right Ventricular Function as measured by myocardial performance index [Time frame: Day 1]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Duke University — Durham
Identifiers
NCT: NCT05262907 · Pro00108548