Ventripoint Single Ventricle Study

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05262907
Status
Recruiting
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Conditions

  • Congenital Heart Disease
  • Single-ventricle

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transthoracic Echocardiogram or Cardiac MRI — DEVICE
    Non-invasive imaging of the heart to evaluate structure and function.
  • Ventripoint Echocardiogram — DEVICE
    Non-invasive ultrasound of the heart to evaluate structure and function through 3D imaging.

Study Details

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.

Key Dates

Start date
Jul 8, 2022
Status verified
Oct 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Ventripoint 3D Echocardiogram
    Ventripoint 3D Echo performed on subject to validate technology for use in single ventricle patients.
  • Active Comparator: Transthoracic Echocardiogram or Cardiac MRI
    Non-invasive imaging of the heart to evaluate structure and function.

Primary Outcome Measure

Cardiac function of the right ventricle as measured by ejection fraction [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27705
Piers Barker, MD
[email protected]

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Duke University· Durham, NC

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