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NCT06134141 Clinical Trial

The Outcome of Interventional Cardiac Catheterization In Pediatric Cardiology Unit, Assiut University Heart Hospital

Cardiac Catheterization Clinical Trial

Official title:
The Outcome of Interventional Cardiac Catheterization In Pediatric Cardiology Unit, Assiut University Heart Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06134141
Other study ID # CC OUTCOME
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 17, 2023
Est. completion date March 31, 2025

Study information
Verified date November 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Describe demographic and clinical data of infant and pediatric with cardiac catheterization who admitted to cardiology unit of Assiut university children hospital Asses outcome of cardiac catheterization in pediatric and infant at AUCH

Description:

Cardiac catheterization and intervention in pediatric cardiac diseases have evolved significantly in the past 30 years. During the last 10 years, there have been major technological achievements in pediatric interventional cardiology There have also been substantial advancements in cardiac imaging modalities, such as intracardiac echocardiography (ICE), real-time 3-dimensional (3D) transesophageal echocardiography (TEE), cardiac computed tomography (CT) and magnetic resonance imaging (MRI), rotational angiography with 3D roadmap, holography, 3D printing, and Echo-Navigator and Vessel-Navigator systems. As a result of such technological advances, more types of congenital heart diseases (CHDs) can be treated in the cardiac catheter laboratory today than ever before. Therefore, the possibility exists that many surgical procedures will be replaced by catheter-based procedures The pediatric interventional cardiology community has continued to develop less invasive solutions for congenital heart defects (CHDs) to minimize the need for open heart surgery and optimize overall outcomes. Many CHDs are effectively managed with transcatheter techniques. Atrial and ventricular septal defects, valve stenosis, patent ductus arteriosus, aortic coarctation, pulmonary artery and vein stenosis and arteriovenous malformations are some examples, routinely treated with catheterization in the pediatric population For most such interventions, these efforts lead to more highly acceptable outcomes and lower complication rates than the alternatives of surgery or no intervention

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date March 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria: children aged 1 month to 18 years old that underwent cardiac catheterization for congenital heart disease management. - Exclusion Criteria: 1-Neonate aged less than 1 month and adult >16 years old 2-Patients with chronic renal and hepatic disease could affect results -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (3)

Backes CH, Cheatham SL, Deyo GM, Leopold S, Ball MK, Smith CV, Garg V, Holzer RJ, Cheatham JP, Berman DP. Percutaneous Patent Ductus Arteriosus (PDA) Closure in Very Preterm Infants: Feasibility and Complications. J Am Heart Assoc. 2016 Feb 12;5(2):e002923. doi: 10.1161/JAHA.115.002923. — View Citation

Crystal MA, Ing FF. Pediatric interventional cardiology: 2009. Curr Opin Pediatr. 2010 Oct;22(5):567-72. doi: 10.1097/MOP.0b013e32833e1328. — View Citation

Moustafa GA, Kolokythas A, Charitakis K, Avgerinos DV. Therapeutic Utilities of Pediatric Cardiac Catheterization. Curr Cardiol Rev. 2016;12(4):258-269. doi: 10.2174/1573403x12666160301121253. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary procedure time [ Time Frame: duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case) ] duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case|) Baseline
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