Status:
COMPLETED
Contrast Enhanced 3D Echocardiographic Quantification of Right Ventricular Volumes in Repaired CHD
Lead Sponsor:
Nemours Children's Clinic
Collaborating Sponsors:
Thomas Jefferson University
Conditions:
Tetralogy of Fallot
Pulmonary Insufficiency
Eligibility:
All Genders
11+ years
Phase:
PHASE1
PHASE2
Brief Summary
We propose the novel integration of two echocardiographic technologies - three-dimensional echocardiography using semi-automated right ventricular analysis coupled with the administration of ultrasoun...
Detailed Description
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 ventricu...
Eligibility Criteria
Inclusion
- 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.
- Informed written consent of parent or legal guardian.
- Informed written assent of subject, if appropriate.
Exclusion
- Any patients in which Lumason is contraindicated (i.e. prior anaphylactoid reaction) will be ineligible for the clinical ultrasound and ineligible for the study.
- 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)
- Pregnant women will be excluded from the study as well since Lumason has not been studied in pregnancy.
Key Trial Info
Start Date :
August 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05186415
Start Date
August 23 2022
End Date
June 25 2024
Last Update
November 28 2025
Active Locations (1)
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1
Nemours Childrens Hospital
Wilmington, Delaware, United States, 19803