Status:
UNKNOWN
Outcomes Of Interventional Catheterization In Infants Less Than 3 Months With Critical Congenital Heart Disease
Lead Sponsor:
YHAlattar
Conditions:
Critical Congenital Heart Disease
Eligibility:
All Genders
12-3 years
Brief Summary
Congenital heart disease is the most common birth defect affecting mostly 1 in 100 births(1), critical congenital heart disease is when there is low systemic cardiac output which requires urgent surge...
Detailed Description
CCHD are classified into three major components: Left heart obstructions representing 30-40%, complete transposition of the great arteries (mostly 30%), and right heart obstructions (20-30%). CCHD m...
Eligibility Criteria
Inclusion
- All infants less than 3 months of age with critical congenital heart disease requiring urgent cardiac catheter intervention including
- Critical valvular aortic stenosis requiring aortic valvuoplasty.
- Pulmonary valvuloplasty for critical valvular pulmonary stenosis.
- Pulmonary valvuloplasty in pulmonary atresia with intact IVS after exclusion of RV-dependent coronary circulation.
- PDA stenting in duct dependent congenital cyanotic heart disease.
- Atrial septostomy to enhance atrial mixing (in transposition of great arteries with restrictive or no inter-atrial communication).
- Balloon angioplasty of native coarctation as a palliative measure to stabilize a patient with severely depressed ventricular function.
Exclusion
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- patent ductus arteriosus closure
- percutaneous temporary pacemaker implantation for arrhythmia
- diagnostic catheterization.
- prematurity
- low birth weight
- bleeding diathesis
- sepsis.
Key Trial Info
Start Date :
June 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05351125
Start Date
June 28 2022
End Date
December 30 2024
Last Update
April 28 2022
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