Clinical trial NCT05262907: Ventripoint Single Ventricle Study
Official title: Assessment of Ventricular Volumes and Function in Single Ventricle Patients Using Ventripoint 3D Echocardiography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Single-ventricle
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Cardiac function of the right ventricle as measured by ejection fraction
timeFrame: Day 1
measure: Cardiac function of the left ventricle as measured by ejection fraction
timeFrame: Day 1
measure: Right ventricular dimension as measured by end diastolic volume
timeFrame: Day 1
measure: Right ventricular dimension as measured by end systolic volume
timeFrame: Day 1
measure: Left Ventricular Dimension as measured by end diastolic volume
timeFrame: Day 1
measure: Left Ventricular Dimension as measured by end systolic volume
timeFrame: Day 1
measure: Left Ventricular Dimension as measured by end diastolic diameter
timeFrame: Day 1
measure: Left Ventricular Dimension as measured by end systolic diameter
timeFrame: Day 1
measure: Right Ventricular Function as measured by tricuspid annular plane systolic excursion
timeFrame: Day 1
measure: Right Ventricular Function as measured by myocardial performance index
timeFrame: Day 1
measure: Left Ventricular Function as measured by myocardial performance index
timeFrame: Day 1
measure: Left Ventricular Function as measured by tissue doppler imaging
timeFrame: Day 1
measure: Left ventricular function as measured by shortening fraction
timeFrame: Day 1
measure: Presence of ventricular dysfunction as measured by strain
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Piers Barker, MD
role: PRINCIPAL_INVESTIGATOR
References: