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

Phase

N/A

Condition

Arrhythmia

Cardiac Disease

Heart Disease

Treatment

electrocardiogram

Clinical Study ID

NCT06260384

FMASU R 139/2022

All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients who have a preexcitation (WPW) pattern on an ECG.

Exclusion

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

Study Design

electrocardiogram

May 01, 2022

October 31, 2024

Study Description

A specifically designed electronic report is used and includes the patient's baseline characteristics, symptoms if present, presence of underlying heart disease, family history of any similar conditions, or sudden cardiac death (SCD).

ECG analysis will be done for criteria of WPW pattern, localization of the site of the accessory pathway, and the algorithm used for that; all will be recorded.

Our sample is divided according to clinical presentation into patients with WPW syndrome (those with symptoms or documented tachycardia) and asymptomatic subjects (ventricular pre-excitation on ECG without symptoms).

In patients with WPW syndrome, data will be collected, including symptoms, type of documented tachyarrhythmia, acute management of this arrhythmia on time, and the long-term management strategy, either pharmacological or interventional therapy.

In patients who are referred for electrophysiological (EP) study for mapping and radiofrequency (RF) catheter ablation, all data are recorded, including the method of the study, either fluoroscopic guided or three-dimensional (3D mapping), acute success, site of successful ablation, complications, and long-term success after a one-year follow-up.

Regarding asymptomatic subjects, we collect data on risk stratification, either a noninvasive assessment like a stress electrocardiogram or an invasive electrophysiological (EP) study, and allowance to do exercise and practice sports.

At the end of the study, the performance of each center regarding the management strategy for WPW syndrome was assessed blindly by two European heart rhythm association (EHRA) certified experts in electrophysiology field based on the recent published guidelines of European society of cardiology (ESC).

Socio-economic determinants and health metrics such as the human development index (HDI), health expenditure as a percentage of the gross demographic product (GDP), and the effective health coverage index (UHC) will be compiled together with the EP procedure density of each center to determine the impact of health governance in the management of patients with cardiac pre-excitation. EP procedure density is defined as the ratio between the number of procedures and the years of experience of the index center.

Connect with a study center

Ain shams university
Cairo, Outside US 11851
Egypt
Active - Recruiting

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