NCT05540769

Holter and ECG Changes After Transcatheter Closure Of ASD In Children

Status unknown NA Last updated 15 September 2022

What this trial tests

NA trial testing catheter guided ASD closure in Atrial Septal Defect in 50 participants. Status unknown.

Timeline

1 June 2022

Primary endpoint
1 June 2023

1 June 2023

Quick facts

Lead sponsor	Sohag University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 June 2022
Primary completion	1 June 2023
Estimated completion	1 June 2023
Sites	1 location across Egypt

Drugs / interventions tested

• catheter guided ASD closure

Conditions studied

• Atrial Septal Defect — all drugs for Atrial Septal Defect →

Sponsor

Sohag University

Who can join

Under 18, any sex, with Atrial Septal Defect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Atrial septal defects (ASD) account for 10% of all congenital heart defects \[1\].

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 \[2\]. Surgical repair, albeit enjoying a high success rate, negligible mortality, and good long-term outcome, is associated with morbidity, discomfort, and thoracotomy scars \[3\]. That is why the transcatheter closure of the ASD has more recently become an alternative to the surgical procedure \[4\].

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\[5,6\].

Cardiac arrhythmias and right chamber enlargement are well known long-term sequelae of atrial septal defect (ASD) \[7\]. Therefore, many authors suggest ASD closure before adulthood \[8,9\].

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 \[10\].

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\[11\].

Publications & conference data

No peer-reviewed publications indexed yet for this trial.