Ventripoint Echocardiography for Single Ventricle Heart
Trial Summary
What is the purpose of this trial?
This trial will test a new 3D ultrasound method to better measure heart size and function in children and young adults with single-ventricle hearts. Current methods struggle with accuracy due to the unique shapes of these hearts. The new technique uses coordinates to create detailed 3D images, aiming for more precise measurements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of this treatment for single ventricle heart conditions?
How is the Ventripoint Echocardiogram treatment different from other treatments for single ventricle heart conditions?
The Ventripoint Echocardiogram is unique because it uses a 3D Echo software application to provide detailed images of the heart, which can improve the accuracy of heart assessments compared to traditional 2D echocardiography. This advanced imaging technique allows for better visualization and understanding of complex heart structures, which is particularly beneficial for conditions like single ventricle heart.678910
Research Team
Piers Barker, MD
Principal Investigator
Duke University
Eligibility Criteria
This trial is for children and young adults with a type of heart disease known as functional single ventricles. Participants can be any age and at any stage of surgical treatment, provided they are undergoing or have undergone a clinically ordered echocardiogram or cardiac MRI.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial assessment using Ventripoint 3D Echocardiogram and comparison with Transthoracic Echocardiogram or Cardiac MRI
Follow-up
Participants are monitored for safety and effectiveness after baseline assessment
Treatment Details
Interventions
- Transthoracic Echocardiogram or Cardiac MRI (Imaging)
- Ventripoint Echocardiogram (Imaging)
Ventripoint Echocardiogram is already approved in Canada for the following indications:
- Cardiac size and function assessment in children and young adults with functional single ventricles
- Congenital heart defects
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor