NCT06719830

Brief Summary

Study of ECG and electrophysiological criteria which discriminate right versus left septal AP (both posteroseptal and anteroseptal AP). Both manifest and concealed APs will be considered .

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
18mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress63%
Nov 2023Nov 2027

Study Start

First participant enrolled

November 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

December 6, 2024

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

November 27, 2024

Last Update Submit

December 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Differentiate right from left septal manifest accessory pathway using ECG

    Onset of delta wave in each lead will be measured from the onset of the earliest delta wave in any of the ECG leads.The polarity of the delta wave will be measured within the initial 20 msec of the preexcitation and will be classified as positive (+), negative (-), or isoelectric (+-). Localization of the site of the accessory pathway will be done using Arruda's algorithm and Fitzpatrick's algorithm

    Baseline

Study Arms (2)

Right group

Septal accessory pathway more to right

Procedure: Radiofrequency ablation

Left group

Septal accessory pathway more to left

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablation of the septal accessory pathway

Left groupRight group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with suggested septal AP (both manifest and concealed AP)

You may qualify if:

  • All patients with suggested septal AP (both manifest and concealed AP) undergoing electrophysiological study and ablation in EP cath lab in cardiology department, Assiut University Heart hospital.

You may not qualify if:

  • Patients with redo AP or failed ablation.
  • Patients with more than one AP.
  • Congenital or structural heart diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Assiut University

Asyut, Asyut Governorate, 71511, Egypt

RECRUITING

Related Publications (12)

  • Lebloa M, Pascale P. Preprocedural Discrimination of Posteroseptal Accessory Pathways Ablated from the Right Endocardium from Those Requiring a Left-sided or Epicardial Coronary Venous Approach. Arrhythm Electrophysiol Rev. 2022 Apr;11:e07. doi: 10.15420/aer.2021.55.

    PMID: 35734142BACKGROUND
  • Jazayeri MR, Dhala A, Deshpande S, Blanck Z, Sra J, Akhtar M. Posteroseptal accessory pathways: an overview of anatomical characteristics, electrocardiographic patterns, electrophysiological features, and ablative therapy. J Interv Cardiol. 1995 Feb;8(1):89-101. doi: 10.1111/j.1540-8183.1995.tb00519.x.

    PMID: 10155221BACKGROUND
  • Sealy WC, Mikat EM. Anatomical problems with identification and interruption of posterior septal Kent bundles. Ann Thorac Surg. 1983 Nov;36(5):584-95. doi: 10.1016/s0003-4975(10)60690-x.

    PMID: 6639196BACKGROUND
  • Guiraudon GM, Klein GJ, Sharma AD, Jones DL, McLellan DG. Surgical ablation of posterior septal accessory pathways in the Wolff-Parkinson-White syndrome by a closed heart technique. J Thorac Cardiovasc Surg. 1986 Sep;92(3 Pt 1):406-13.

    PMID: 3528678BACKGROUND
  • Sun Y, Arruda M, Otomo K, Beckman K, Nakagawa H, Calame J, Po S, Spector P, Lustgarten D, Herring L, Lazzara R, Jackman W. Coronary sinus-ventricular accessory connections producing posteroseptal and left posterior accessory pathways: incidence and electrophysiological identification. Circulation. 2002 Sep 10;106(11):1362-7. doi: 10.1161/01.cir.0000028464.12047.a6.

    PMID: 12221053BACKGROUND
  • Calkins H, Yong P, Miller JM, Olshansky B, Carlson M, Saul JP, Huang SK, Liem LB, Klein LS, Moser SA, Bloch DA, Gillette P, Prystowsky E. Catheter ablation of accessory pathways, atrioventricular nodal reentrant tachycardia, and the atrioventricular junction: final results of a prospective, multicenter clinical trial. The Atakr Multicenter Investigators Group. Circulation. 1999 Jan 19;99(2):262-70. doi: 10.1161/01.cir.99.2.262.

    PMID: 9892593BACKGROUND
  • Tai CT, Chen SA, Chiang CE, Lee SH, Chang MS. Electrocardiographic and electrophysiologic characteristics of anteroseptal, midseptal, and para-Hisian accessory pathways. Implication for radiofrequency catheter ablation. Chest. 1996 Mar;109(3):730-40. doi: 10.1378/chest.109.3.730.

    PMID: 8617084BACKGROUND
  • Letsas KP, Efremidis M, Vlachos K, Georgopoulos S, Karamichalakis N, Saplaouras A, Xydonas S, Valkanas K, Sideris A. Catheter ablation of anteroseptal accessory pathways from the aortic cusps: A case series and a review of the literature. J Arrhythm. 2016 Dec;32(6):443-448. doi: 10.1016/j.joa.2016.02.010. Epub 2016 Apr 19.

    PMID: 27920827BACKGROUND
  • Xu G, Liu T, Liu E, Ye L, Shehata M, Wang X, Li G. Radiofrequency catheter ablation at the non-coronary cusp for the treatment of para-hisian accessory pathways. Europace. 2015 Jun;17(6):962-8. doi: 10.1093/europace/euu271. Epub 2014 Oct 29.

    PMID: 25355782BACKGROUND
  • Arruda MS, McClelland JH, Wang X, Beckman KJ, Widman LE, Gonzalez MD, Nakagawa H, Lazzara R, Jackman WM. Development and validation of an ECG algorithm for identifying accessory pathway ablation site in Wolff-Parkinson-White syndrome. J Cardiovasc Electrophysiol. 1998 Jan;9(1):2-12. doi: 10.1111/j.1540-8167.1998.tb00861.x.

    PMID: 9475572BACKGROUND
  • Pambrun T, El Bouazzaoui R, Combes N, Combes S, Sousa P, Le Bloa M, Massoullie G, Cheniti G, Martin R, Pillois X, Duchateau J, Sacher F, Hocini M, Jais P, Derval N, Bortone A, Boveda S, Denis A, Haissaguerre M, Albenque JP. Maximal Pre-Excitation Based Algorithm for Localization of Manifest Accessory Pathways in Adults. JACC Clin Electrophysiol. 2018 Aug;4(8):1052-1061. doi: 10.1016/j.jacep.2018.03.018. Epub 2018 May 30.

    PMID: 30139487BACKGROUND
  • Fitzpatrick AP, Gonzales RP, Lesh MD, Modin GW, Lee RJ, Scheinman MM. New algorithm for the localization of accessory atrioventricular connections using a baseline electrocardiogram. J Am Coll Cardiol. 1994 Jan;23(1):107-16. doi: 10.1016/0735-1097(94)90508-8.

    PMID: 8277067BACKGROUND

MeSH Terms

Conditions

Wolff-Parkinson-White SyndromePre-Excitation Syndromes

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Central Study Contacts

Antony Youssef, Bachelor

CONTACT

Marwan Sayed, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Cardiovascular Medicine

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 6, 2024

Study Start

November 1, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

December 6, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations