Ventripoint Single Ventricle Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Transthoracic Echocardiogram or Cardiac MRI
DeviceNon-invasive imaging of the heart to evaluate structure and function.
Ventripoint Echocardiogram
DeviceNon-invasive ultrasound of the heart to evaluate structure and function through 3D imaging.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Ventripoint 3D EchocardiogramExperimental treatment 1 intervention
Group B: Transthoracic Echocardiogram or Cardiac MRIActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 12
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.
Time frame
Day 13
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.
Time frame
Day 14
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.
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov