Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06761807

Electrocardiographic and Electrophysiologic Changes After Percutaneous Closure of Atrial Septal Defect

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No exclusion

Treatment and study plan

Electrophysiology study of heart

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

Primary outcomes

  1. 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

  2. incidence of AVN dysfunction

    Time frame: baseline

    incidence of AVN dysfunction before and after percutaneous ASD closure

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma Osama, Master student

CONTACT

[email protected]

01032772709

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.