Holter and ECG Changes After Transcatheter Closure Of ASD In Children

NCT05540769 | Unknown

• 1 other identifier: Soh-Med-22-04-19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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\[11\].

Conditions

Atrial Septal Defect

Outcome Measures

Primary Outcomes (4)

• 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 \[HR\]

  1 month , 6 months , 1 year

• 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 .

  1 month , 6 months , 1 year

• 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 \[HR\]

  1 month , 6 months , 1 year

• 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 .

  1 month , 6 months , 1 year

Study Arms (1)

case group

EXPERIMENTAL

Procedure: catheter guided ASD closure

Interventions

catheter guided ASD closure PROCEDURE

transcatheter secundum ASD device closure

case group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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 .

You may not qualify if:

• \- Failure to obtain informed consent .

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

• 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: 2233961 BACKGROUND

• 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: 7090997 BACKGROUND

• 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: 16598516 BACKGROUND

• 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.

  PMID: 15708695 BACKGROUND

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Marwa A Abdelgalil, resident

CONTACT

01099575181; marwaabdelgalil@med.sohag.edu.eg

Safaa H Ali, professor

CONTACT

01064818849

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at pediatric department at faculty of medicine sohag university hospital

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: September 15, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)