WPW SyndromeNCT06719830
Discrimination of Right Versus Left Septal Accessory Pathway Before and During the Electrophysiological Study
An observational study of WPW Syndrome and Accessory Pathway, run by Assiut University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- WPW Syndrome, Accessory Pathway
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with suggested septal AP (both manifest and concealed AP)
Who may be able to join
- 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.
Who cannot join
- Patients with redo AP or failed ablation.
- Patients with more than one AP.
- Congenital or structural heart diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Assiut University
Asyut, Asyut Governorate, 71511
Salah El-Dein Sayed Atta, Professor, +201091318801, salah_s_atta@hotmail.com
Marwan Sayed Mahmoud, Lecturer, +201090686492, marwancordio@aun.edu.eg
About this study
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 .
Read the detailed description
Radiofrequency catheter ablation is now the preferred treatment for patients with symptomatic Wolff-Parkinson-White (WPW) syndrome or recurrent symptomatic orthodromic reciprocating tachycardia . Successful ablation depends on the accurate localization of the accessory pathway (AP). Posteroseptal (inferior paraseptal) APs represent the second most common atrioventricular (AV) connection site after left free wall AP and often pose a diagnostic challenge. This is due to complex anatomy at the crux of the four cardiac chambers, where a small area may encompass APs that may be approached from the right or left endocardium, or require an epicardial ablation inside the coronary sinus (CS).
APs located in the posteroseptal area can take a variety of courses. Four different course types may be distinguished.
- Endocardially between the inferior paraseptal right atrium and the right ventricle. This area includes the inferior part of the Koch's triangle and the area surrounding the CS ostium.
- Endocardially between the inferior paraseptal left atrium and the left ventricle.
- Coursing between the inferior paraseptal right atrium and the left ventricle in the pyramidal space, given that the right atrium lies directly on the posterior superior process of the left ventricle. This anatomical conformation results from the fact that the interatrial septum lies leftward to the interventricular septum and the tricuspid annulus is displaced 5-10 mm apically with respect to the mitral annulus. The right atrial endocardial aspect overlying the posterior superior process of the left ventricle lies between the most posterior aspect of the right fibrous trigone and the CS ostium, medial to the tricuspid valve. Because of its close proximity, ablation of these APs may be possible from the proximal CS.
- Epicardially, connecting the musculature overlying the CS to the ventricle. These connections are related to sleeve-like extensions of the CS musculature that cover the proximal portion of the middle cardiac vein or posterior coronary veins. Most of these APs are ablated with a coronary venous These APs are referred to as 'epicardial CS' APs.
The procedural risks of inferior paraseptal AP ablation differ depending on whether a left-sided approach or a CS ablation is required .
Anteroseptal Aps are rare but associated with lower success rates and higher incidence of atrioventricular(AV) block. Anteroseptal AP can be ablated from right side , however Some including true para-Hisian APs can be safely and effectively ablated from the aortic cusps. Compared with the ablation at the right anteroseptal area, RF delivered at the aortic cusps has a higher immediate success, lower complication rate, and good long-term outcome. The aortic cusps should always be considered as the initial target for ablation of para-Hisian Aps . Data regarding the electro- cardiographic and electrophysiological characteristics as well as the safety and efficacy of catheter ablation of anteroseptal APs through the aortic cusps are limited Considering these differences, an accurate anticipation of location of septal AP is critical to inform the discussion and consent process with the patient and to guide the mapping strategy.
- Conditions
- WPW Syndrome, Accessory Pathway
- Being tested
- Radiofrequency ablation
- Medical subject headings
- Wolff-Parkinson-White Syndrome, Pre-Excitation Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
Radiofrequency ablation of the septal accessory pathway
| Study group | Role | What they receive |
|---|---|---|
| Right group | Septal accessory pathway more to right Receives: Procedure: Radiofrequency ablation | |
| Left group | Septal accessory pathway more to left Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Nov 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for WPW SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Sayed Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719830
- Sponsor's protocol ID
- EPS for accessory pathway
- Status last verified
- Sep 2024
- First submitted
- 27 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35734142Jazayeri 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.
PubMed 10155221Sealy 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.
PubMed 6639196Guiraudon 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.
PubMed 3528678Sun 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.
PubMed 12221053Calkins 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.
PubMed 9892593Tai 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.
PubMed 8617084Letsas 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.
PubMed 27920827Xu 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.
PubMed 25355782Arruda 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.
PubMed 9475572Pambrun 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.
PubMed 30139487Fitzpatrick 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.
PubMed 8277067
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discrimination of Right Versus Left Septal Accessory Pathway Before and During the Electrophysiological Study
- ClinicalTrials.gov ID
- NCT06719830
- Acronym / sponsor ID
- EPS for accessory pathway
- Conditions
- WPW Syndrome, Accessory Pathway
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
Radiofrequency catheter ablation is now the preferred treatment for patients with symptomatic Wolff-Parkinson-White (WPW) syndrome or recurrent symptomatic orthodromic reciprocating tachycardia . Successful ablation depends on the accurate localization of the accessory pathway (AP). Posteroseptal (inferior paraseptal) APs represent the second most common atrioventricular (AV) connection site after left free wall AP and often pose a diagnostic challenge. This is due to complex anatomy at the crux of the four cardiac chambers, where a small area may encompass APs that may be approached from the right or left endocardium, or require an epicardial ablation inside the coronary sinus (CS).
APs located in the posteroseptal area can take a variety of courses. Four different course types may be distinguished.
- Endocardially between the inferior paraseptal right atrium and the right ventricle. This area includes the inferior part of the Koch's triangle and the area surrounding the CS ostium.
- Endocardially between the inferior paraseptal left atrium and the left ventricle.
- Coursing between the inferior paraseptal right atrium and the left ventricle in the pyramidal space, given that the right atrium lies directly on the posterior superior process of the left ventricle. This anatomical conformation results from the fact that the interatrial septum lies leftward to the interventricular septum and the tricuspid annulus is displaced 5-10 mm apically with respect to the mitral annulus. The right atrial endocardial aspect overlying the posterior superior process of the left ventricle lies between the most posterior aspect of the right fibrous trigone and the CS ostium, medial to the tricuspid valve. Because of its close proximity, ablation of these APs may be possible from the proximal CS.
- Epicardially, connecting the musculature overlying the CS to the ventricle. These connections are related to sleeve-like extensions of the CS musculature that cover the proximal portion of the middle cardiac vein or posterior coronary veins. Most of these APs are ablated with a coronary venous These APs are referred to as 'epicardial CS' APs.
The procedural risks of inferior paraseptal AP ablation differ depending on whether a left-sided approach or a CS ablation is required .
Anteroseptal Aps are rare but associated with lower success rates and higher incidence of atrioventricular(AV) block. Anteroseptal AP can be ablated from right side , however Some including true para-Hisian APs can be safely and effectively ablated from the aortic cusps. Compared with the ablation at the right anteroseptal area, RF delivered at the aortic cusps has a higher immediate success, lower complication rate, and good long-term outcome. The aortic cusps should always be considered as the initial target for ablation of para-Hisian Aps . Data regarding the electro- cardiographic and electrophysiological characteristics as well as the safety and efficacy of catheter ablation of anteroseptal APs through the aortic cusps are limited Considering these differences, an accurate anticipation of location of septal AP is critical to inform the discussion and consent process with the patient and to guide the mapping strategy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right group | – | Procedure: Radiofrequency ablationSeptal accessory pathway more to right |
| Left group | – | Procedure: Radiofrequency ablationSeptal accessory pathway more to left |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with suggested septal AP (both manifest and concealed AP)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with redo AP or failed ablation.
- Patients with more than one AP.
- Congenital or structural heart diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablationRadiofrequency ablation of the septal accessory pathway | Procedure or surgery | Left group, Right group |
Primary outcome
Differentiate right from left septal manifest accessory pathway using ECG
Time frame: Baseline
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 35734142Lebloa 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.
- Background: PubMed 10155221Jazayeri 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.
- Background: PubMed 6639196Sealy 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.
- Background: PubMed 3528678Guiraudon 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.
- Background: PubMed 12221053Sun 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.
- Background: PubMed 9892593Calkins 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.
- Background: PubMed 8617084Tai 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.
- Background: PubMed 27920827Letsas 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.
- Background: PubMed 25355782Xu 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.
- Background: PubMed 9475572Arruda 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.
- Background: PubMed 30139487Pambrun 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.
- Background: PubMed 8277067Fitzpatrick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of WPW Syndrome and Accessory Pathway, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antony Youssef, Bachelor (+201281106216, tony.sameh9771@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentiate right from left septal manifest accessory pathway using ECG (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06719830, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.