Ventripoint Single Ventricle Study

Congenital Heart Disease Clinical Trial

Official title:

Assessment of Ventricular Volumes and Function in Single Ventricle Patients Using Ventripoint 3D Echocardiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05262907
• Other study ID #: Pro00108548
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: Joan Wilson
• Phone: 999999999
• Email: joan.wilson[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Single-ventricle
• Univentricular Heart

Intervention

Device:
• Transthoracic Echocardiogram or Cardiac MRI
Non-invasive imaging of the heart to evaluate structure and function.
• Ventripoint Echocardiogram
Non-invasive ultrasound of the heart to evaluate structure and function through 3D imaging.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac function of the right ventricle as measured by ejection fraction	Ejection Fraction (EF) is a measurement of the percentage of blood leaving your heart each time it squeezes (contracts)with each heart beat.	Day 1
Primary	Cardiac function of the left ventricle as measured by ejection fraction	Ejection Fraction (EF) is a measurement of the percentage of blood leaving your heart each time it squeezes (contracts)with each heart beat.	Day 1
Primary	Right ventricular dimension as measured by end diastolic volume	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.	Day 1
Primary	Right ventricular dimension as measured by end systolic volume	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.	Day 1
Primary	Left Ventricular Dimension as measured by end diastolic volume	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.	Day 1
Primary	Left Ventricular Dimension as measured by end systolic volume	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.	Day 1
Primary	Left Ventricular Dimension as measured by end diastolic diameter	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.	Day 1
Primary	Left Ventricular Dimension as measured by end systolic diameter	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.	Day 1
Primary	Right Ventricular Function as measured by tricuspid annular plane systolic excursion	Tricuspid Annular Plane Systolic Excursion (TAPSE) is a measurement of the decent of the right ventricular base towards a relatively fixed apex.	Day 1
Primary	Right Ventricular Function as measured by myocardial performance index	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.	Day 1
Primary	Left Ventricular Function as measured by myocardial performance index	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.	Day 1
Primary	Left Ventricular Function as measured by tissue doppler imaging	Tissue Doppler Imaging (TDI) a measurement of the velocity of myocardial motion.	Day 1
Primary	Left ventricular function as measured by shortening fraction	Shortening fraction(SF) is a measurement of the percentage of change in left ventricular diameter during systole.	Day 1
Primary	Presence of ventricular dysfunction as measured by strain	Strain is a measure of deformity in the muscle of the ventricle.	Day 1