Status:
UNKNOWN
Early Right Ventricular Function After Repair Of Tetralogy Of Fallot , An Evidence Based Study.
Lead Sponsor:
Assiut University
Conditions:
Tetralogy of Fallot
Eligibility:
All Genders
6-12 years
Brief Summary
This study aims to assessing right ventricular function early after surgical repair of tetralogy of Fallot and identifying the risk factors associated with development of RV dysfunction.
Detailed Description
The shape of the RV is dramatically modified by surgical repair of CHD, with infundibular bulging and apical dilation and deformation, leading to a large range of RV shapes(1,2). Moreover, pericardial...
Eligibility Criteria
Inclusion
- Pediatric patients up to 12 years old.
- Recent echocardiography before the surgery giving detailed data about the components congenital anomalies of tetralogy of Fallot and if there are other associated congenital anomalies.
- Obtaining written informed consent from parents or guardians of all patients confirming their willing and comply with study requirements
- Parents or guardians of the Patient are willing to comply with all follow-up visits.
Exclusion
- Patients with tetralogy of Fallot who are indicated to palliative procedures and not for definitive surgical repair as in case of:-
- Neonates with TOF and pulmonary atresia
- Children with hypoplastic pulmonary artery
- Age less than 3 months who have medically unmanageable hypoxic spells
- Infant weight less than 2.5 kg
- Abnormal coronary artery anatomy
- Patients with TOF who are contraindicated to primary repair as in case of:-
- Multiple VSDs
- Multiple coexisting intracardiac malformations
- Small pulmonary arteries
- Very low birth weight
- The presence of an anomalous coronary artery
- Patient inaccessible for follow-up visits required by protocol.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03470064
Start Date
April 1 2018
End Date
October 1 2022
Last Update
July 21 2022
Active Locations (2)
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1
Assiut University
Asyut, Egypt, 71515
2
Assiut University
Asyut, Egypt