ASDNCT06761807
Electrocardiographic and Electrophysiologic Changes After Percutaneous Closure of Atrial Septal Defect
A study testing Electrophysiology study of heart in people with ASD and Brady Arrythmia, run by Assiut University.
Trial summary
Primary outcomes : Determining the incidence of SAN and AVN dysfunction before and after percutaneous ASD closure Comparing ECG and EP parameters of SAN and AVN before and after percutaneous ASD closure Secondary outcomes : Assessing clinical, echocardiographic and procedural risk factors affecting the AVN function… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ASD, Brady Arrythmia
- What is being tested?
- Electrophysiology study of heart
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2025to 2 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients presented with secundum ASD eligible for percutaneous transcatheter ASD closure at Assiut university heart hospital
Who cannot join
- No exclusion
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Primary outcomes :
Determining the incidence of SAN and AVN dysfunction before and after percutaneous ASD closure Comparing ECG and EP parameters of SAN and AVN before and after percutaneous ASD closure
Secondary outcomes :
Assessing clinical, echocardiographic and procedural risk factors affecting the AVN function after ASD closure device implantation Determining the incidence of supraventricular arrhythmia inducibility before and after percutaneous ASD closure
Read the detailed description
Atrial septal defects (ASDs) are one of the most common types of acyanotic congenital heart diseases, comprising 6-10% all congenital heart defects. They represent the most common congenital heart disease diagnosed during adulthood. Secundum ASD is a defect in the fossa ovalis (septum primum), or the superior limb of the septum secundum and is the most common type of ASD (80% of all ASDs).
ASD closure for secundum ASD is recommended regardless of symptoms in patients with evidence of right ventricular (RV) volume overload and no pulmonary arterial hypertension (PAH) or left ventricular (LV) disease. Percutaneous device closure has become the first choice for secundum defect closure in presence of a feasible morphology with a reported low risk of serious complications (≤1% of patients).
Subclinical electrocardiography (ECG) abnormalities, sinoatrial node (SAN) and atrioventricular node (AVN) conduction abnormalities have been reported in patients with ASDs. . The reported incidence of AVN block following ASD device closure varies widely from none up to 6.1%. High-grade AVN block after device closure typically occurs in the first 24-hour post-procedure and may mandates device removal for resolution of heart block.
The mechanism of AVN block after ASD device occlusion could be due to mechanical pressure on the AV node or edema related to trauma. Young age and large defect/device size may be a risk factor for AVN block. Deficient rims of the ASD may also have an impact on development of AVN block.
Whether or not there is a direct impact of ASD device closure on the functional properties of AVN and SAN is not well elucidated. Testing the electrocardiographic and electrophysiologic (EP) parameters of AVN and SAN before and after the procedure could obviously help understanding the real risk
- Conditions
- ASD, Brady Arrythmia
- Being tested
- Electrophysiology study of heart
- Keywords
- ASD, EPD, Brady arrythmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiology study of heartProcedure or surgery
The procedure will be done comparatively for each patient; before the device placement and immediately after the procedure.
This will be done approaching the same sheath that is placed for ASD device closure (the right femoral vein).
Only one quadripolar EP catheter will be used, it will be placed in high right atrium then at His bundle.
The EP study will include:
Assessment of SAN function using cSNRT (through HRA pacing) Assessment of AH and HV intervals (through His bundle EGM) Assessment of antegrade AVN RP (refractory period) and AVN WP (Wenckebach point) through extra-stimuli and incremental atrial pacing.
Any inducible arrhythmia will be reported
| Study group | Role | What they receive |
|---|---|---|
| Incidence of AV node dysfunction after ASD Closure | Experimental | Determining the incidence of SAN and AVN dysfunction before and after percutaneous ASD closure Comparing ECG and EP parameters of SAN and AVN before and after percutaneous ASD closure Receives: Procedure: Electrophysiology study of heart |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of SAN dysfunction
Determining the incidence of SAN and AVN dysfunction before and after percutaneous ASD closure Comparing ECG and EP parameters of SAN and AVN before and after percutaneous ASD closure
Measured: baseline
incidence of AVN dysfunction
incidence of AVN dysfunction before and after percutaneous ASD closure
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion2 Nov 2026 (estimated)
- Study completion2 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ASDStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Osama Ali Ezz el_deen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761807
- Sponsor's protocol ID
- EPS and ASD
- Status last verified
- Jan 2025
- First submitted
- 19 Nov 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asakai H, Weskamp S, Eastaugh L, d'Udekem Y, Pflaumer A. Atrioventricular block after ASD closure. Heart Asia. 2016 Aug 1;8(2):26-31. doi: 10.1136/heartasia-2016-010745. eCollection 2016.
PubMed 27540418Hill SL, Berul CI, Patel HT, Rhodes J, Supran SE, Cao QL, Hijazi ZM. Early ECG abnormalities associated with transcatheter closure of atrial septal defects using the Amplatzer septal occluder. J Interv Card Electrophysiol. 2000 Oct;4(3):469-74. doi: 10.1023/a:1009852312907.
PubMed 11046184Fischer G, Stieh J, Uebing A, Hoffmann U, Morf G, Kramer HH. Experience with transcatheter closure of secundum atrial septal defects using the Amplatzer septal occluder: a single centre study in 236 consecutive patients. Heart. 2003 Feb;89(2):199-204. doi: 10.1136/heart.89.2.199.
PubMed 12527678Butera G, Carminati M, Chessa M, Youssef R, Drago M, Giamberti A, Pome G, Bossone E, Frigiola A. Percutaneous versus surgical closure of secundum atrial septal defect: comparison of early results and complications. Am Heart J. 2006 Jan;151(1):228-34. doi: 10.1016/j.ahj.2005.02.051.
PubMed 16368323Bartakian S, Fagan TE, Schaffer MS, Darst JR. Device closure of secundum atrial septal defects in children <15 kg: complication rates and indications for referral. JACC Cardiovasc Interv. 2012 Nov;5(11):1178-84. doi: 10.1016/j.jcin.2012.07.009.
PubMed 23174643
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiographic and Electrophysiologic Changes After Percutaneous Closure of Atrial Septal Defect
- ClinicalTrials.gov ID
- NCT06761807
- Acronym / sponsor ID
- EPS and ASD
- Conditions
- ASD, Brady Arrythmia
- Keywords
- ASD, EPD, Brady arrythmia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 2 Nov 2027 (estimated)
- First posted
- 7 Jan 2025 (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.
Primary outcomes :
Determining the incidence of SAN and AVN dysfunction before and after percutaneous ASD closure Comparing ECG and EP parameters of SAN and AVN before and after percutaneous ASD closure
Secondary outcomes :
Assessing clinical, echocardiographic and procedural risk factors affecting the AVN function after ASD closure device implantation Determining the incidence of supraventricular arrhythmia inducibility before and after percutaneous ASD closure
Detailed description
Atrial septal defects (ASDs) are one of the most common types of acyanotic congenital heart diseases, comprising 6-10% all congenital heart defects. They represent the most common congenital heart disease diagnosed during adulthood. Secundum ASD is a defect in the fossa ovalis (septum primum), or the superior limb of the septum secundum and is the most common type of ASD (80% of all ASDs).
ASD closure for secundum ASD is recommended regardless of symptoms in patients with evidence of right ventricular (RV) volume overload and no pulmonary arterial hypertension (PAH) or left ventricular (LV) disease. Percutaneous device closure has become the first choice for secundum defect closure in presence of a feasible morphology with a reported low risk of serious complications (≤1% of patients).
Subclinical electrocardiography (ECG) abnormalities, sinoatrial node (SAN) and atrioventricular node (AVN) conduction abnormalities have been reported in patients with ASDs. . The reported incidence of AVN block following ASD device closure varies widely from none up to 6.1%. High-grade AVN block after device closure typically occurs in the first 24-hour post-procedure and may mandates device removal for resolution of heart block.
The mechanism of AVN block after ASD device occlusion could be due to mechanical pressure on the AV node or edema related to trauma. Young age and large defect/device size may be a risk factor for AVN block. Deficient rims of the ASD may also have an impact on development of AVN block.
Whether or not there is a direct impact of ASD device closure on the functional properties of AVN and SAN is not well elucidated. Testing the electrocardiographic and electrophysiologic (EP) parameters of AVN and SAN before and after the procedure could obviously help understanding the real risk
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incidence of AV node dysfunction after ASD Closure | Experimental | Procedure: Electrophysiology study of heartDetermining the incidence of SAN and AVN dysfunction before and after percutaneous ASD closure Comparing ECG and EP parameters of SAN and AVN before and after percutaneous ASD closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients presented with secundum ASD eligible for percutaneous transcatheter ASD closure at Assiut university heart hospital
Key exclusion criteria (1 listed)
- No exclusion
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 |
|---|---|---|
| Electrophysiology study of heartThe procedure will be done comparatively for each patient; before the device placement and immediately after the procedure. This will be done approaching the same sheath that is placed for ASD device closure (the right femoral vein). Only one quadripolar EP catheter will be used, it will be placed in high right atrium then at His bundle. The EP study will include: Assessment of SAN function using cSNRT (through HRA pacing) Assessment of AH and HV intervals (through His bundle EGM) Assessment of antegrade AVN RP (refractory period) and AVN WP (Wenckebach point) through extra-stimuli and incremental atrial pacing. Any inducible arrhythmia will be reported | Procedure or surgery | Incidence of AV node dysfunction after ASD Closure |
Primary outcome
incidence of SAN dysfunction
Time frame: baseline
Determining the incidence of SAN and AVN dysfunction before and after percutaneous ASD closure Comparing ECG and EP parameters of SAN and AVN before and after percutaneous ASD closure
incidence of AVN dysfunction
Time frame: baseline
incidence of AVN dysfunction before and after percutaneous ASD closure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Results publication: PubMed 27540418Asakai H, Weskamp S, Eastaugh L, d'Udekem Y, Pflaumer A. Atrioventricular block after ASD closure. Heart Asia. 2016 Aug 1;8(2):26-31. doi: 10.1136/heartasia-2016-010745. eCollection 2016.
- Results publication: PubMed 11046184Hill SL, Berul CI, Patel HT, Rhodes J, Supran SE, Cao QL, Hijazi ZM. Early ECG abnormalities associated with transcatheter closure of atrial septal defects using the Amplatzer septal occluder. J Interv Card Electrophysiol. 2000 Oct;4(3):469-74. doi: 10.1023/a:1009852312907.
- Results publication: PubMed 12527678Fischer G, Stieh J, Uebing A, Hoffmann U, Morf G, Kramer HH. Experience with transcatheter closure of secundum atrial septal defects using the Amplatzer septal occluder: a single centre study in 236 consecutive patients. Heart. 2003 Feb;89(2):199-204. doi: 10.1136/heart.89.2.199.
- Results publication: PubMed 16368323Butera G, Carminati M, Chessa M, Youssef R, Drago M, Giamberti A, Pome G, Bossone E, Frigiola A. Percutaneous versus surgical closure of secundum atrial septal defect: comparison of early results and complications. Am Heart J. 2006 Jan;151(1):228-34. doi: 10.1016/j.ahj.2005.02.051.
- Results publication: PubMed 23174643Bartakian S, Fagan TE, Schaffer MS, Darst JR. Device closure of secundum atrial septal defects in children <15 kg: complication rates and indications for referral. JACC Cardiovasc Interv. 2012 Nov;5(11):1178-84. doi: 10.1016/j.jcin.2012.07.009.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiology study of heart in people with ASD and Brady Arrythmia, run by Assiut University.
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: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Osama, Master student (01032772709, fatmaosama748130@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of SAN dysfunction (time frame: baseline). 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 NCT06761807, which also lists 5 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 7 Jan 2025.