NCT06761807

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Jan 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2025Nov 2027

First Submitted

Initial submission to the registry

November 19, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

January 20, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2027

Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

November 19, 2024

Last Update Submit

January 6, 2025

Conditions

ASDBrady Arrythmia

Keywords

ASDEPDBrady arrythmia

Outcome Measures

Primary Outcomes (2)

  • 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

    baseline

  • incidence of AVN dysfunction

    incidence of AVN dysfunction before and after percutaneous ASD closure

    baseline

Study Arms (1)

Incidence of AV node dysfunction after ASD Closure

EXPERIMENTAL

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

Interventions

Electrophysiology study of heartPROCEDURE

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

Incidence of AV node dysfunction after ASD Closure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 27540418BACKGROUND

  • 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.

    PMID: 11046184BACKGROUND

  • 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.

    PMID: 12527678BACKGROUND

  • 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.

    PMID: 16368323BACKGROUND

  • 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.

    PMID: 23174643BACKGROUND

Central Study Contacts

Fatma Osama, Master student

CONTACT

01032772709fatmaosama748130@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

November 19, 2024

First Posted

January 7, 2025

Study Start

January 20, 2025

Primary Completion (Estimated)

November 2, 2026

Study Completion (Estimated)

November 2, 2027

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share