Ventripoint Single Ventricle Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; Single-ventricle
• Intervention / Treatment: Device: Ventripoint Echocardiogram; Device: Transthoracic Echocardiogram or Cardiac MRI

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joan Wilson; Phone Number: 999999999; Email: joan.wilson@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University
      • Contact: Piers Barker, MD; Email: piers.barker@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ventripoint 3D Echocardiogram; Ventripoint 3D Echo performed on subject to validate technology for use in single ventricle patients.	Device: Ventripoint Echocardiogram; Non-invasive ultrasound of the heart to evaluate structure and function through 3D imaging.
Active Comparator: Transthoracic Echocardiogram or Cardiac MRI; Non-invasive imaging of the heart to evaluate structure and function.	Device: Transthoracic Echocardiogram or Cardiac MRI; Non-invasive imaging of the heart to evaluate structure and function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
Left Ventricular Function as measured by tissue doppler imaging	Tissue Doppler Imaging (TDI) a measurement of the velocity of myocardial motion.	Day 1
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
Presence of ventricular dysfunction as measured by strain	Strain is a measure of deformity in the muscle of the ventricle.	Day 1

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Piers Barker, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: February 21, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Univentricular Heart
• Other Study ID Numbers: Pro00108548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No