Status:
COMPLETED
Transcatheter Versus Surgical Closure of Ventricular Septal Defect: A Comparative Study
Lead Sponsor:
Ain Shams University
Conditions:
Heart Defects, Congenital
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
The aim of this study is to compare Safety, efiicacy and clinical effects of surgical versus transcatheter closure of ventricular septal defect (VSD ). The outcome of interest is success rate, residu...
Detailed Description
Both of transcatheter and surgical closure of VSD is a well-established procedure. Despite the wide using of both procedures, there is a defect in the evidence comparing the short-term outcome and the...
Eligibility Criteria
Inclusion
- Ventricular septal defect: All patients who have congenital VSD which require intervention and accepting the selected measure of intervention. Surgery closure for Perimembranous VSD which is not suitable for catheter closure, muscular VSD. Catheter closure for Perimembranous VSD with at least 4 mm distal from aortic valve, mid muscular, anterior muscular.
- Age: Pediatric age group with minimum age of 10 months to 18 years old.
- Gender: both males and females.
- Intervention classification: Elective.
- NYHA classification: I - III
- weight more than 8 Kg.
- left to right shunt with Qp/Qs more than 1.5.
Exclusion
- Non-congenital VSD.
- severe pulmonary hypertension with right to left shunt.
- ischemic stroke
- hemorrhage stroke
- systemic thromboembolism
- heart failure
- rheumatic heart disease
- cardiac valvular abnormalities
- infective endocarditis
- high degree atrioventricular block
- atrial fibrillation, atrial flutter
- paroxysmal supraventricular tachycardia
- endocardial cushing syndome,
- Ebstein's anomaly
- hemodynamically significant atrial septal defect
- transposition of great vessels
- tetralogy of Fallot.
Key Trial Info
Start Date :
June 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05306483
Start Date
June 12 2020
End Date
June 15 2021
Last Update
April 13 2022
Active Locations (1)
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1
Hamdy Singab
Cairo, Egypt, 11517