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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05262907
Other study ID # Pro00108548
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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