Wolf-Parkinson-White Syndrome and Asymptomatic Pre-excitation in Africa (a Multicenter WPW African Registry)

NCT06260384 | Recruiting

• 1 other identifier: FMASU R 139/2022
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective observational study is to characterize the clinical profile of patients with WPW syndrome and patients with asymptomatic WPW pattern on ECG in different African countries and how these patients are managed across Africa Participants would include many different ethnicities at centers where the number of cardiac patients treated is high. All patients attending outpatient cardiology clinics or referred to Cath Lab for electrophysiological studies who are diagnosed to have a Wolf-Parkinson white pattern on the ECG are either symptomatic or asymptomatic. All patients fulfilling the eligibility criteria will be approached by the research team and asked if they wish to take part in the study. The exclusion criteria will be any participant who does not consent to the study. A baseline cardiovascular history (including hypertension, diabetes, heart failure, coronary artery disease, hyperlipidemia, smoking, valve disease, and arrhythmia) will be recorded. A detailed history will be taken about symptoms, medications and presence of family history of similar cases or sudden cardiac death 12-lead ECG will be recorded to confirm the presence of pre-excitation and determine the localization of the accessory pathway using the modified Aruda algorithm. This will be done by two of the research teams in each center. Then other data from the electrophysiological study and ablation will be filled in by the research team from the data systems of each center.

Conditions

Wolf Parkinson White Syndrome; Arrythmias

Keywords

WPW syndrome; ECG; RF ablation; Africa

Outcome Measures

Primary Outcomes (2)

• No recurrence of symptoms

  Disappearance of symptoms after proper management either pharmacological or intervention method based on ESC guidelines on management of supraventricular tachycardia

  12 months

• Assessment of performance outcome of each center

  Assessment of quality of management of each shared center in managing the study population based on the recent guidelines

  12 months

Study Arms (1)

All patients attending outpatient cardiology clinics or referred for EP study

Participants will be recruited from outpatient cardiology clinics and inpatient cardiology wards at twenty cardiac centers in 17 countries spread across all African regions. They all belong to the Africa Heart Rhythm Association (AFHRA) network, and participants are included if they have a preexcitation (WPW) pattern on an ECG. A written consent will be obtained, and an ethical clearance from each center will be obtained from their institution. The exclusion criteria were a lack of consent.

Other: electrocardiogram

Interventions

electrocardiogram OTHER

it is a non-invasive study to diagnose criteria of Wolf-Parkinson-Wall syndrome and detect any arrhythmias

All patients attending outpatient cardiology clinics or referred for EP study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are recruited from outpatient cardiology clinics and inpatient cardiology wards at twenty cardiac centers in 17 countries spread across all African regions. They all belong to the Africa Heart Rhythm Association (AFHRA) network, and participants were included if they have preexcitation (WPW) pattern on an ECG either they have symptoms, documented tachyarrhythmias or asymptomatic and accidently discovered

You may qualify if:

• Patients who have a preexcitation (WPW) pattern on an ECG.

You may not qualify if:

• any participant who does not consent to the study. Any participants who have structural heart disease History of other arrhythmogenic diseases like Brugada syndrome, Arrhythmogenic AR dysplasia, long QT syndrome..etc Any implantable cardiac rhythm devices

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Outside US, 11851, Egypt

RECRUITING

Related Publications (2)

• Svendsen JH, Dagres N, Dobreanu D, Bongiorni MG, Marinskis G, Blomstrom-Lundqvist C; Scientific Initiatives Committee, European Heart Rhythm Association. Current strategy for treatment of patients with Wolff-Parkinson-White syndrome and asymptomatic preexcitation in Europe: European Heart Rhythm Association survey. Europace. 2013 May;15(5):750-3. doi: 10.1093/europace/eut094.

  PMID: 23625944 RESULT

• Brugada J, Katritsis DG, Arbelo E, Arribas F, Bax JJ, Blomstrom-Lundqvist C, Calkins H, Corrado D, Deftereos SG, Diller GP, Gomez-Doblas JJ, Gorenek B, Grace A, Ho SY, Kaski JC, Kuck KH, Lambiase PD, Sacher F, Sarquella-Brugada G, Suwalski P, Zaza A; ESC Scientific Document Group. 2019 ESC Guidelines for the management of patients with supraventricular tachycardiaThe Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J. 2020 Feb 1;41(5):655-720. doi: 10.1093/eurheartj/ehz467. No abstract available.

  PMID: 31504425 RESULT

MeSH Terms

Conditions

Wolff-Parkinson-White Syndrome

Condition Hierarchy (Ancestors)

Pre-Excitation Syndromes; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• lamyaa E Allam, MD

  Ain shams university,Cairo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lamyaa E Allam, MD

CONTACT

+201004002084; lamyaa_allam@med.asu.edu.eg

Amie Bonny, MD

CONTACT

+237694543990; aimebonny@yahoo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: May 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)