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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Catheterization

Detailed 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

• Study Type: Observational
• Enrollment (Estimated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

children aged 1 month to 18 years old that underwent cardiac catheterization for congenital heart disease management.

Description

Inclusion Criteria:

children aged 1 month to 18 years old that underwent cardiac catheterization for congenital heart disease management.

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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

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Estimated): November 17, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CC OUTCOME

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No