Clinical trial NCT06761807: Electrocardiographic and Electrophysiologic Changes After Percutaneous Closure of Atrial Septal Defect
Official title: Electrocardiographic and Electrophysiologic Changes After Percutaneous Closure of Atrial Septal Defect
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ASD
Brady Arrythmia
Keywords: ASD
EPD
Brady arrythmia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: incidence of SAN dysfunction
timeFrame: baseline
measure: incidence of AVN dysfunction
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.