Ventripoint Single Ventricle Study
- Conditions
- Congenital Heart DiseaseSingle-ventricle
- Interventions
- Device: Transthoracic Echocardiogram or Cardiac MRIDevice: Ventripoint Echocardiogram
- Registration Number
- NCT05262907
- Lead Sponsor
- Duke University
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transthoracic Echocardiogram or Cardiac MRI Transthoracic Echocardiogram or Cardiac MRI Non-invasive imaging of the heart to evaluate structure and function. Ventripoint 3D Echocardiogram Ventripoint Echocardiogram Ventripoint 3D Echo performed on subject to validate technology for use in single ventricle patients.
- Primary Outcome Measures
Name Time Method Cardiac function of the right ventricle as measured by ejection fraction Day 1 Ejection Fraction (EF) is a measurement of the percentage of blood leaving your heart each time it squeezes (contracts)with each heart beat.
Left Ventricular Dimension as measured by end systolic diameter Day 1 End Systolic Diameter (ESD) is the diameter across the left ventricle of the heart at the end of systole, that is, when the heart muscle is maximally contracted, and usually corresponds to its smallest diameter.
Left Ventricular Function as measured by tissue doppler imaging Day 1 Tissue Doppler Imaging (TDI) a measurement of the velocity of myocardial motion.
Cardiac function of the left ventricle as measured by ejection fraction Day 1 Ejection Fraction (EF) is a measurement of the percentage of blood leaving your heart each time it squeezes (contracts)with each heart beat.
Left Ventricular Dimension as measured by end systolic volume Day 1 End Systolic Volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.
Right Ventricular Function as measured by tricuspid annular plane systolic excursion Day 1 Tricuspid Annular Plane Systolic Excursion (TAPSE) is a measurement of the decent of the right ventricular base towards a relatively fixed apex.
Left ventricular function as measured by shortening fraction Day 1 Shortening fraction(SF) is a measurement of the percentage of change in left ventricular diameter during systole.
Presence of ventricular dysfunction as measured by strain Day 1 Strain is a measure of deformity in the muscle of the ventricle.
Right Ventricular Function as measured by myocardial performance index Day 1 RV Myocardial Performance Index (MPI) is a measurement that incorporates tricuspid valve closure to opening time and right ventricular ejection time to evaluate efficiency of the ventricle.
Right ventricular dimension as measured by end diastolic volume Day 1 End Diastolic Volume (EDV) is the volume of blood in a ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole.
Right ventricular dimension as measured by end systolic volume Day 1 End Systolic Volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.
Left Ventricular Dimension as measured by end diastolic volume Day 1 End Diastolic Volume (EDV) is the volume of blood in a ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole.
Left Ventricular Dimension as measured by end diastolic diameter Day 1 End Diastolic Diameter (EDD) is the diameter across the left ventricle of the heart at the end of diastole, that is, when the heart muscle is maximally relaxed, and usually corresponds to its largest diameter.
Left Ventricular Function as measured by myocardial performance index Day 1 LV Myocardial Performance Index (MPI) is a measurement that incorporates mitral valve closure to opening time and left ventricular ejection time to evaluate efficiency of the ventricle.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Duke University
🇺🇸Durham, North Carolina, United States