Clinical trial NCT05540769: Holter and ECG Changes After Transcatheter Closure Of ASD In Children
Official title: Holter and ECG Changes After Transcatheter Closure Of ASD In Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Septal Defect
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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\[11\].

Detailed description: The Aim Of Work:

The focus of this study is to describe the electrocardiography (ECG) changes 1,6,12 months after ASD transcatheter device closure in a pediatric population.

Patients and Method:

* Place of the Study: Cardiac catheterization unit , pediatric department , Sohag university hospital .
* Type of the Study: Prospective observational study.
* Study Period: 12 months (starting from the date of obtaining the approval from the research ethics committee) .
* Patients:
* 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 .

Ethical consideration Approval will be obtained from the medical research ethics committee (MREC) of faculty of medicine Sohag university .Informed consent will be obtained from parent or authorized legal representative of all children included in the study .

* Methods of the Study:
* The following data will be collected from all patients:

  \*Demographic data:
  * Name , Age , sex and Residence .

    \*Medical history:
  * General medical history will be obtained .
* All patients will be subjected to :

  * 12 leads ECG (Fukuda Denshi CardiMax ECG device model FCP-7101 with a 25 mm/s paper speed, gain 10 mm/mV) the day before and the day after the procedure
  * Holter ECG (Mortara H3+ Holter ECG) the day before and the day after the procedure.
  * Clinical , ECG and Holter follow-up will be obtained at 1, 6 and 12 months respectively.

Statistical analysis:

The collected data will be statistically analyzed and expressed in tables and charts.

Conclusions and recommendations will be suggested based on the results.

Eligibility criteria: 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 .

Primary outcomes:
measure: ECG changes in Heart rate [HR] before and after the catheter guided ASD device closure
timeFrame: 1 month , 6 months , 1 year
measure: ECG changes before and after the catheter guided ASD device closure
timeFrame: 1 month , 6 months , 1 year
measure: Holter ECG changes in Heart rate [HR] before and after the ASD closure
timeFrame: 1 month , 6 months , 1 year
measure: Holter ECG changes before and after the ASD closure
timeFrame: 1 month , 6 months , 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Murphy JG, Gersh BJ, McGoon MD, Mair DD, Porter CJ, Ilstrup DM, McGoon DC, Puga FJ, Kirklin JW, Danielson GK. Long-term outcome after surgical repair of isolated atrial septal defect. Follow-up at 27 to 32 years. N Engl J Med. 1990 Dec 13;323(24):1645-50. doi: 10.1056/NEJM199012133232401.
citation: Meyer RA, Korfhagen JC, Covitz W, Kaplan S. Long-term follow-up study after closure of secundum atrial septal defect in children: an echocardiographic study. Am J Cardiol. 1982 Jul;50(1):143-8. doi: 10.1016/0002-9149(82)90020-0.
citation: 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.
citation: 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.