Holter and ECG Changes After Transcatheter Closure Of ASD In Children
Primary Purpose
Atrial Septal Defect
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
catheter guided ASD closure
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Septal Defect
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 .
Sites / Locations
- Sohag University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
case group
Arm Description
Outcomes
Primary Outcome Measures
ECG changes in Heart rate [HR] before and after the catheter guided ASD device closure
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
-Heart rate [HR]
ECG changes before and after the catheter guided ASD device closure
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 ECG PR interval , ECG QRS interval , ECG axis , and ECG corrected QT interval "QTc" will be recorded .
Holter ECG changes in Heart rate [HR] before and after the ASD closure
Holter ECG (Mortara H3+ Holter ECG) changes the day before and the day after the procedure.
Heart rate [HR]
Holter ECG changes before and after the ASD closure
Holter ECG (Mortara H3+ Holter ECG) changes the day before and the day after the procedure.
ECG PR interval , ECG QRS interval , ECG axis , and ECG corrected QT interval "QTc" will be recorded .
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05540769
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Septal Defect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
case group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
catheter guided ASD closure
Intervention Description
transcatheter secundum ASD device closure
Primary Outcome Measure Information:
Title
ECG changes in Heart rate [HR] before and after the catheter guided ASD device closure
Description
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
-Heart rate [HR]
Time Frame
1 month , 6 months , 1 year
Title
ECG changes before and after the catheter guided ASD device closure
Description
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 ECG PR interval , ECG QRS interval , ECG axis , and ECG corrected QT interval "QTc" will be recorded .
Time Frame
1 month , 6 months , 1 year
Title
Holter ECG changes in Heart rate [HR] before and after the ASD closure
Description
Holter ECG (Mortara H3+ Holter ECG) changes the day before and the day after the procedure.
Heart rate [HR]
Time Frame
1 month , 6 months , 1 year
Title
Holter ECG changes before and after the ASD closure
Description
Holter ECG (Mortara H3+ Holter ECG) changes the day before and the day after the procedure.
ECG PR interval , ECG QRS interval , ECG axis , and ECG corrected QT interval "QTc" will be recorded .
Time Frame
1 month , 6 months , 1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa A Abdelgalil, resident
Phone
01099575181
Email
marwaabdelgalil@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Safaa H Ali, professor
Phone
01064818849
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R Elshrif, professor
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
2233961
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.
Results Reference
background
PubMed Identifier
7090997
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.
Results Reference
background
PubMed Identifier
16598516
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.
Results Reference
background
PubMed Identifier
15708695
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.
Results Reference
background
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Holter and ECG Changes After Transcatheter Closure Of ASD In Children
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