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Contrast Enhanced 3D Echocardiographic Quantification of Right Ventricular Volumes in Repaired CHD

NCT05186415 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-27

Study results available
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Summary

We propose the novel integration of two echocardiographic technologies - three-dimensional echocardiography using semi-automated right ventricular analysis coupled with the administration of ultrasound enhancing agents - to improve the inter-rater reliability and accuracy of various measures of right ventricular size and function, compared with cardiac MRI.

Conditions

  • Tetralogy of Fallot
  • Pulmonary Insufficiency

Interventions

DRUG

Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]

The patient will receive the weight-based dose of Lumason of 0.03 mL/kg per injection, not to exceed 2.4 mL per injection per the FDA and manufacturer recommendations.

Sponsors & Collaborators

  • Thomas Jefferson University

    collaborator OTHER

  • Nemours Children's Clinic

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-23
Primary Completion
2024-06-25
Completion
2024-06-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05186415 on ClinicalTrials.gov