Ventripoint Single Ventricle Study
NCT05262907 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-10-23
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.
Conditions
- Congenital Heart Disease
- Single-ventricle
Interventions
- DEVICE
-
Transthoracic Echocardiogram or Cardiac MRI
Non-invasive imaging of the heart to evaluate structure and function.
- DEVICE
-
Ventripoint Echocardiogram
Non-invasive ultrasound of the heart to evaluate structure and function through 3D imaging.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Piers Barker, MD · Duke University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-08
- Primary Completion
- 2027-08-31
- Completion
- 2027-08-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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