Holter and ECG Changes After Trancatheter Closure Of ASD In Children

Atrial septal defects (ASD) account for 10% of all congenital heart defects . Hemodynamic consequences of an ASD are dilatation of the right atrium and right ventricle (RV) because of the volume overload due to the left-to-right shunt through the ASD.For several decades, surgical closure has been considered the standard method of repairing a secundum ASD . Surgical repair, albeit enjoying a high success rate, negligible mortality, and good long-term outcome, is associated with morbidity, discomfort, and thoracotomy scars. That is why the transcatheter closure of the ASD has more recently become an alternative to the surgical procedure . During the last decade , ASD device closure , has finally replaced surgical ASD repair in most patients as the standard method of repair for the secundum ASD Cardiac arrhythmias and right chamber enlargement are well known long-term sequelae of atrial septal defect (ASD) . Therefore, many authors suggest ASD closure before adulthood . Classical ECG findings for a significant ASD are prolongation of the PR interval, prolongation of the QRS duration and right axis deviation of the QRS .

Percutaneous ASD closure is an ideal situation to study changes of RV dimensions and their impact on ECG as interferences from cardiopulmonary bypass, cardiac incisions and sutures on the right atrium and on the interatrial septum are excluded

Study Overview

• Status: Completed
• Conditions: ASD II
• Intervention / Treatment: Device: Fukuda Denshi Cardimax ECG device model FCP-7101

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Egypt
  • Suhag
    • Sohag, Suhag, Egypt
      • Sohag University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

- All children under the age of 18 years diagnosed with ASD , that will undergo transcatheter secundum ASD device closure during the period of the study .

Description

Inclusion Criteria:

• All children under the age of 18 years diagnosed with ASD , that will undergo transcatheter secundum ASD device closure during the period of the study .

Exclusion Criteria:

• Failure to obtain informed consent .

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECG Changes after transcatheter closure of ASD	ECG will be done one day before and one day after then after 1,6,12 month of ASD closure , determination of the following variables ; heart rate, QRS axis, PR interval , QRS duration and the QT interval . Interpretation of every ECG paper was done using specific centile tables for normal values of ECG waves and intervals according to age . ECG will be examined for any abnormal rhythm (heart block, ectopics ,supraventricular or ventricular tachycardia) .	one year
HOLTER ECG Changes after transcatheter closure of ASD	Six channel Holter ECG will be used for recording the day before , the day after the procedure then repeated at 1m,6m and 12m . the recordings will be used for evaluation of mean HR, Mean QTC interval duration .	one year

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Peters B, Ewert P, Schubert S, Abdul-Khaliq H, Schmitt B, Nagdyman N, Berger F. Self-fabricated fenestrated Amplatzer occluders for transcatheter closure of atrial septal defect in patients with left ventricular restriction: midterm results. Clin Res Cardiol. 2006 Feb;95(2):88-92. doi: 10.1007/s00392-006-0329-3. Epub 2006 Jan 16.
• Masura J, Gavora P, Podnar T. Long-term outcome of transcatheter secundum-type atrial septal defect closure using Amplatzer septal occluders. J Am Coll Cardiol. 2005 Feb 15;45(4):505-7. doi: 10.1016/j.jacc.2004.10.066.
• Celiker A, Ozkutlu S, Karagoz T, Ayabakan C, Bilgic A. Transcatheter closure of interatrial communications with Amplatzer device: results, unfulfilled attempts and special considerations in children and adolescents. Anadolu Kardiyol Derg. 2005 Sep;5(3):159-64.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: January 7, 2024
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-22-04-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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