Electrocardiographic and Electrophysiologic Changes After Percutaneous Closure of Atrial Septal Defect

January 6, 2025 updated by: Fatma Osama Ali Ezz el_deen, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline
incidence of AVN dysfunction
Time Frame: baseline
incidence of AVN dysfunction before and after percutaneous ASD closure
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 20, 2025

Primary Completion (Estimated)

November 2, 2026

Study Completion (Estimated)

November 2, 2027

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPS and ASD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ASD

Clinical Trials on Electrophysiology study of heart

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe