Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-27 @ 11:04 AM
Study NCT ID:
NCT05540769
Status:
UNKNOWN
Last Update Posted:
2022-09-15
First Post:
2022-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Holter and ECG Changes After Transcatheter Closure Of ASD In Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}], 'ancestors': [{'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-14', 'studyFirstSubmitDate': '2022-08-14', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ECG changes in Heart rate [HR] before and after the catheter guided ASD device closure', 'timeFrame': '1 month , 6 months , 1 year', '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\n\n-Heart rate \\[HR\\]'}, {'measure': 'ECG changes before and after the catheter guided ASD device closure', 'timeFrame': '1 month , 6 months , 1 year', '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 .'}, {'measure': 'Holter ECG changes in Heart rate [HR] before and after the ASD closure', 'timeFrame': '1 month , 6 months , 1 year', 'description': 'Holter ECG (Mortara H3+ Holter ECG) changes the day before and the day after the procedure.\n\nHeart rate \\[HR\\]'}, {'measure': 'Holter ECG changes before and after the ASD closure', 'timeFrame': '1 month , 6 months , 1 year', 'description': 'Holter ECG (Mortara H3+ Holter ECG) changes the day before and the day after the procedure.\n\nECG PR interval , ECG QRS interval , ECG axis , and ECG corrected QT interval "QTc" will be recorded .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Septal Defect']}, 'referencesModule': {'references': [{'pmid': '2233961', 'type': 'BACKGROUND', '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.'}, {'pmid': '7090997', 'type': 'BACKGROUND', '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.'}, {'pmid': '16598516', 'type': 'BACKGROUND', '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.'}, {'pmid': '15708695', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Atrial septal defects (ASD) account for 10% of all congenital heart defects \\[1\\].\n\nHemodynamic 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\\].\n\nDuring 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\\].\n\nCardiac 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\\].\n\nClassical 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\\].\n\nPercutaneous 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\\].', 'detailedDescription': 'The Aim Of Work:\n\nThe focus of this study is to describe the electrocardiography (ECG) changes 1,6,12 months after ASD transcatheter device closure in a pediatric population.\n\nPatients and Method:\n\n* Place of the Study: Cardiac catheterization unit , pediatric department , Sohag university hospital .\n* Type of the Study: Prospective observational study.\n* Study Period: 12 months (starting from the date of obtaining the approval from the research ethics committee) .\n* Patients:\n* Inclusion Criteria:\n* 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 .\n* Exclusion Criteria:\n* Failure to obtain informed consent .\n\nEthical 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 .\n\n* Methods of the Study:\n* The following data will be collected from all patients:\n\n \\*Demographic data:\n * Name , Age , sex and Residence .\n\n \\*Medical history:\n * General medical history will be obtained .\n* All patients will be subjected to :\n\n * 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\n * Holter ECG (Mortara H3+ Holter ECG) the day before and the day after the procedure.\n * Clinical , ECG and Holter follow-up will be obtained at 1, 6 and 12 months respectively.\n\nStatistical analysis:\n\nThe collected data will be statistically analyzed and expressed in tables and charts.\n\nConclusions and recommendations will be suggested based on the results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- 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 .\n\nExclusion Criteria:\n\n* \\- Failure to obtain informed consent .'}, 'identificationModule': {'nctId': 'NCT05540769', 'briefTitle': 'Holter and ECG Changes After Transcatheter Closure Of ASD In Children', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Holter and ECG Changes After Transcatheter Closure Of ASD In Children', 'orgStudyIdInfo': {'id': 'Soh-Med-22-04-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'case group', 'interventionNames': ['Procedure: catheter guided ASD closure']}], 'interventions': [{'name': 'catheter guided ASD closure', 'type': 'PROCEDURE', 'description': 'transcatheter secundum ASD device closure', 'armGroupLabels': ['case group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Osama R Elshrif, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Marwa A Abdelgalil, resident', 'role': 'CONTACT', 'email': 'marwaabdelgalil@med.sohag.edu.eg', 'phone': '01099575181'}, {'name': 'Safaa H Ali, professor', 'role': 'CONTACT', 'phone': '01064818849'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at pediatric department at faculty of medicine sohag university hospital', 'investigatorFullName': 'Marwa Ahmed Abdel Galil', 'investigatorAffiliation': 'Sohag University'}}}}