Ventripoint Single Ventricle Study

Last updated: October 21, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congenital Heart Disease

Heart Disease

Pentalogy Of Cantrell

Treatment

Ventripoint Echocardiogram

Transthoracic Echocardiogram or Cardiac MRI

Clinical Study ID

NCT05262907
Pro00108548
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients with functional single ventricles will be included, regardless of ageor surgical palliation stage, who have had or are having a clinically orderedtransthoracic echocardiogram and/or cardiac MRI.

Exclusion

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 orconsent in English will be excluded.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Ventripoint Echocardiogram
Phase:
Study Start date:
July 08, 2022
Estimated Completion Date:
August 31, 2027

Study 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.

Connect with a study center

  • Duke University

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Duke University

    Durham 4464368, North Carolina 4482348 27705
    United States

    Active - Recruiting

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