Clinical Profile and Current Strategies in Management of Wolf-Parkinson-White Syndrome and Asymptomatic Pre-excitation in Africa (a Multicenter WPW African Registry)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- No recurrence of symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have a preexcitation (WPW) pattern on an ECG.
排除标准
- •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
结局指标
主要结局
No recurrence of symptoms
时间窗: 12 months
Disappearance of symptoms after proper management either pharmacological or intervention method based on ESC guidelines on management of supraventricular tachycardia
Assessment of performance outcome of each center
时间窗: 12 months
Assessment of quality of management of each shared center in managing the study population based on the recent guidelines
次要结局
未报告次要终点