Electrocardiographic and Electrophysiologic Changes After Percutaneous Closure of Atrial Septal Defect

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

No exclusion

Trial design

Design model

Single group

Treatments tested in this trial

  • Electrophysiology study of heart

    Procedure/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

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: Incidence of AV node dysfunction after ASD ClosureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
baseline
2

incidence of AVN dysfunction

incidence of AVN dysfunction before and after percutaneous ASD closure

Time frame
baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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