Ventripoint Single Ventricle Study
Primary Purpose
Congenital Heart Disease, Single-ventricle
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transthoracic Echocardiogram or Cardiac MRI
Ventripoint Echocardiogram
Sponsored by
About this trial
This is an interventional diagnostic trial for Congenital Heart Disease
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.
Sites / Locations
- Duke UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ventripoint 3D Echocardiogram
Transthoracic Echocardiogram or Cardiac MRI
Arm Description
Ventripoint 3D Echo performed on subject to validate technology for use in single ventricle patients.
Non-invasive imaging of the heart to evaluate structure and function.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Left Ventricular Function as measured by tissue doppler imaging
Tissue Doppler Imaging (TDI) a measurement of the velocity of myocardial motion.
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.
Presence of ventricular dysfunction as measured by strain
Strain is a measure of deformity in the muscle of the ventricle.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05262907
Brief Title
Ventripoint Single Ventricle Study
Official Title
Assessment of Ventricular Volumes and Function in Single Ventricle Patients Using Ventripoint 3D Echocardiography
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2022 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Single-ventricle
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ventripoint 3D Echocardiogram
Arm Type
Experimental
Arm Description
Ventripoint 3D Echo performed on subject to validate technology for use in single ventricle patients.
Arm Title
Transthoracic Echocardiogram or Cardiac MRI
Arm Type
Active Comparator
Arm Description
Non-invasive imaging of the heart to evaluate structure and function.
Intervention Type
Device
Intervention Name(s)
Transthoracic Echocardiogram or Cardiac MRI
Intervention Description
Non-invasive imaging of the heart to evaluate structure and function.
Intervention Type
Device
Intervention Name(s)
Ventripoint Echocardiogram
Intervention Description
Non-invasive ultrasound of the heart to evaluate structure and function through 3D imaging.
Primary Outcome Measure Information:
Title
Cardiac function of the right ventricle as measured by ejection fraction
Description
Ejection Fraction (EF) is a measurement of the percentage of blood leaving your heart each time it squeezes (contracts)with each heart beat.
Time Frame
Day 1
Title
Cardiac function of the left ventricle as measured by ejection fraction
Description
Ejection Fraction (EF) is a measurement of the percentage of blood leaving your heart each time it squeezes (contracts)with each heart beat.
Time Frame
Day 1
Title
Right ventricular dimension as measured by end diastolic volume
Description
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.
Time Frame
Day 1
Title
Right ventricular dimension as measured by end systolic volume
Description
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.
Time Frame
Day 1
Title
Left Ventricular Dimension as measured by end diastolic volume
Description
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.
Time Frame
Day 1
Title
Left Ventricular Dimension as measured by end systolic volume
Description
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.
Time Frame
Day 1
Title
Left Ventricular Dimension as measured by end diastolic diameter
Description
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.
Time Frame
Day 1
Title
Left Ventricular Dimension as measured by end systolic diameter
Description
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.
Time Frame
Day 1
Title
Right Ventricular Function as measured by tricuspid annular plane systolic excursion
Description
Tricuspid Annular Plane Systolic Excursion (TAPSE) is a measurement of the decent of the right ventricular base towards a relatively fixed apex.
Time Frame
Day 1
Title
Right Ventricular Function as measured by myocardial performance index
Description
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.
Time Frame
Day 1
Title
Left Ventricular Function as measured by myocardial performance index
Description
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.
Time Frame
Day 1
Title
Left Ventricular Function as measured by tissue doppler imaging
Description
Tissue Doppler Imaging (TDI) a measurement of the velocity of myocardial motion.
Time Frame
Day 1
Title
Left ventricular function as measured by shortening fraction
Description
Shortening fraction(SF) is a measurement of the percentage of change in left ventricular diameter during systole.
Time Frame
Day 1
Title
Presence of ventricular dysfunction as measured by strain
Description
Strain is a measure of deformity in the muscle of the ventricle.
Time Frame
Day 1
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joan Wilson
Phone
999999999
Email
joan.wilson@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piers Barker, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piers Barker, MD
Email
piers.barker@duke.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Ventripoint Single Ventricle Study
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