NCT05262907

Ventripoint Single Ventricle Study

Assessment of Ventricular Volumes and Function in Single Ventricle Patients Using Ventripoint 3D Echocardiography

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Disease
• Single-ventricle

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-08
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2022-03-02
• Last updated: 2025-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study