ASD IINCT06197191
Holter and ECG Changes After Trancatheter Closure Of ASD In Children
An observational study of ASD II, run by Sohag University at 1 site in Egypt.
Trial summary
Atrial septal defects (ASD) account for 10% of all congenital heart defects . 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- ASD II
- What is being tested?
- Fukuda Denshi Cardimax ECG device model FCP-7101
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 15 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: - 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 .
Who may be able to join
- 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 .
Who cannot join
- Failure to obtain informed consent .
Trial locations and contacts
1 site in 1 country.
About this study
Atrial septal defects (ASD) account for 10% of all congenital heart defects . 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 . Surgical repair, albeit enjoying a high success rate, negligible mortality, and good long-term outcome, is associated with morbidity, discomfort, and thoracotomy scars. That is why the transcatheter closure of the ASD has more recently become an alternative to the surgical procedure . 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 Cardiac arrhythmias and right chamber enlargement are well known long-term sequelae of atrial septal defect (ASD) . Therefore, many authors suggest ASD closure before adulthood . 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 .
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
- Conditions
- ASD II
- Being tested
- Fukuda Denshi Cardimax ECG device model FCP-7101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fukuda Denshi Cardimax ECG device model FCP-7101Device
Also called Holter ECG mortara H3+
ecg and holter will be done one day before and one day after then after 1,6,12 month after transcatheter closure of ASD
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG Changes after transcatheter closure of ASD
ECG will be done one day before and one day after then after 1,6,12 month of ASD closure , determination of the following variables ; heart rate, QRS axis, PR interval , QRS duration and the QT interval . Interpretation of every ECG paper was done using specific centile tables for normal values of ECG waves and intervals according to age . ECG will be examined for any abnormal rhythm (heart block, ectopics ,supraventricular or ventricular tachycardia) .
Measured: one year
HOLTER ECG Changes after transcatheter closure of ASD
Six channel Holter ECG will be used for recording the day before , the day after the procedure then repeated at 1m,6m and 12m . the recordings will be used for evaluation of mean HR, Mean QTC interval duration .
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Apr 2022
- Primary completion1 Apr 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ASD IIStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Abdelgalil, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197191
- Sponsor's protocol ID
- Soh-Med-22-04-12
- Status last verified
- Jan 2024
- First submitted
- 17 Apr 2022
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Celiker A, Ozkutlu S, Karagoz T, Ayabakan C, Bilgic A. Transcatheter closure of interatrial communications with Amplatzer device: results, unfulfilled attempts and special considerations in children and adolescents. Anadolu Kardiyol Derg. 2005 Sep;5(3):159-64.
PubMed 16140642Masura 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.
PubMed 15708695Peters 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.
PubMed 16598516
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holter and ECG Changes After Trancatheter Closure Of ASD In Children
- ClinicalTrials.gov ID
- NCT06197191
- Acronym / sponsor ID
- Soh-Med-22-04-12
- Conditions
- ASD II
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial septal defects (ASD) account for 10% of all congenital heart defects . 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 . Surgical repair, albeit enjoying a high success rate, negligible mortality, and good long-term outcome, is associated with morbidity, discomfort, and thoracotomy scars. That is why the transcatheter closure of the ASD has more recently become an alternative to the surgical procedure . 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 Cardiac arrhythmias and right chamber enlargement are well known long-term sequelae of atrial septal defect (ASD) . Therefore, many authors suggest ASD closure before adulthood . 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 .
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- - 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 .
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (1 listed)
- Failure to obtain informed consent .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fukuda Denshi Cardimax ECG device model FCP-7101Also: Holter ECG mortara H3+ecg and holter will be done one day before and one day after then after 1,6,12 month after transcatheter closure of ASD | Device | – |
Primary outcome
ECG Changes after transcatheter closure of ASD
Time frame: one year
ECG will be done one day before and one day after then after 1,6,12 month of ASD closure , determination of the following variables ; heart rate, QRS axis, PR interval , QRS duration and the QT interval . Interpretation of every ECG paper was done using specific centile tables for normal values of ECG waves and intervals according to age . ECG will be examined for any abnormal rhythm (heart block, ectopics ,supraventricular or ventricular tachycardia) .
HOLTER ECG Changes after transcatheter closure of ASD
Time frame: one year
Six channel Holter ECG will be used for recording the day before , the day after the procedure then repeated at 1m,6m and 12m . the recordings will be used for evaluation of mean HR, Mean QTC interval duration .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 16140642Celiker A, Ozkutlu S, Karagoz T, Ayabakan C, Bilgic A. Transcatheter closure of interatrial communications with Amplatzer device: results, unfulfilled attempts and special considerations in children and adolescents. Anadolu Kardiyol Derg. 2005 Sep;5(3):159-64.
- Background: PubMed 15708695Masura 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.
- Background: PubMed 16598516Peters 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ASD II, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG Changes after transcatheter closure of ASD (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06197191, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.