Electrocardiographic and Electrophysiologic Changes After Percutaneous Closure of Atrial Septal Defect

NCT ID: NCT06761807

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2027-11-02

Brief 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 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

Conditions

ASD; Brady Arrythmia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Incidence of AV node dysfunction after ASD Closure

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

Group Type: EXPERIMENTAL

Electrophysiology study of heart

Intervention Type: PROCEDURE

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

Interventions

Electrophysiology study of heart

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All patients presented with secundum ASD eligible for percutaneous transcatheter ASD closure at Assiut university heart hospital

Exclusion Criteria

• No exclusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Osama Ali Ezz el_deen

Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Fatma Osama, Master student

Role: CONTACT

fatmaosama748130@gmail.com

01032772709

References

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.

Reference Type: BACKGROUND

PMID: 27540418 (View on PubMed)

Hill 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.

Reference Type: BACKGROUND

PMID: 11046184 (View on PubMed)

Fischer 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.

Reference Type: BACKGROUND

PMID: 12527678 (View on PubMed)

Butera 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.

Reference Type: BACKGROUND

PMID: 16368323 (View on PubMed)

Bartakian 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.

Reference Type: BACKGROUND

PMID: 23174643 (View on PubMed)

Other Identifiers

EPS and ASD

Identifier Type: -

Identifier Source: org_study_id