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Search / Trial NCT05186415

Contrast Enhanced Three Dimensional Echocardiographic Quantification of Right Ventricular Volumes in Repaired Congenital Heart Disease

Launched by NEMOURS CHILDREN'S CLINIC · Jan 10, 2022

Trial Information

Current as of April 30, 2025

Completed

Keywords

Ultrasound Enhancing Agent Echocardiography Lumason

ClinConnect Summary

Patients with repaired congenital heart disease with residual pulmonary insufficiency represent a challenging group of patients with congenital heart disease as they develop progressive right ventricular dilation and failure, increasing the risk for sudden cardiac death and often necessitating pulmonary valve replacement. These patients require close follow-up with serial cardiac imaging; however, the complex three-dimensional structure of these dilated right ventricles renders them difficult to adequately image with traditional two-dimensional echocardiography. Due to these difficulties, c...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. All patients aged 11 or greater with repaired congenital heart disease and residual pulmonary insufficiency who are referred to Nemours A.I. DuPont Hospital for Children for clinically indicated cardiac MRI will be eligible for inclusion.
  • 2. Informed written consent of parent or legal guardian.
  • 3. Informed written assent of subject, if appropriate.
  • Exclusion Criteria:
  • 1. Any patients in which Lumason is contraindicated (i.e. prior anaphylactoid reaction) will be ineligible for the clinical ultrasound and ineligible for the study.
  • 2. History of allergic reaction to Lumason, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
  • 3. Pregnant women will be excluded from the study as well since Lumason has not been studied in pregnancy.

About Nemours Children's Clinic

Nemours Children's Clinic is a leading pediatric healthcare organization dedicated to enhancing the health and well-being of children through innovative clinical care, research, and education. As a prominent clinical trial sponsor, Nemours is committed to advancing pediatric medicine by conducting rigorous clinical trials that explore new treatments and therapies. The clinic's multidisciplinary team of experts collaborates closely with families and community partners to ensure that research initiatives are aligned with the unique needs of children. With a focus on safety, efficacy, and ethical standards, Nemours Children's Clinic aims to foster breakthroughs that will improve health outcomes for children and adolescents.

Locations

Wilmington, Delaware, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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