Registry on Electrophysiological Studies (EPS) at University Hospital Düsseldorf
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Periprocedural and postprocedural safety events
研究概览
简要总结
This registry at University Hospital Düsseldorf collects retrospective and prospective (from 2019 onward) data on patients undergoing electrophysiological studies (EPS), catheter ablation, and electrical cardioversion. The primary goal is to evaluate safety, efficacy, and clinical outcomes of these standard procedures in routine care. Data will be used for quality assurance and to identify prognostic patient- and procedure-related factors.
详细描述
This is a single-center observational registry including all patients treated with EPS, catheter ablation, or electrical cardioversion at the Department of Cardiology, Pneumology, and Angiology, University Hospital Düsseldorf. Retrospective data from 2011 onward and prospective data from 2015 onward are collected.
The registry systematically records demographic data, comorbidities, laboratory and imaging results, procedural details, and follow-up outcomes. Patients are routinely followed at 1, 3, 6, 12, and 24 months after the procedure. Additional follow-up may be performed by telephone interview with patients or referring physicians to improve data quality.
Primary endpoints focus on safety (peri- and postprocedural complications, late adverse events) and efficacy (recurrence of arrhythmias, need for repeat procedures, pacemaker implantation, or new medications). Secondary endpoints include hospitalization and all-cause mortality.
Participation does not alter routine diagnostic or therapeutic decisions, and no additional invasive procedures are performed. Data will be used for quality assurance and to improve understanding of prognostic factors, with the ultimate aim of optimizing future patient care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo an electrophysiological study (EPS) or electrical cardioversion at University Hospital Düsseldorf since 2015 (retrospective cohort)
- •Patients scheduled to undergo an EPS or electrical cardioversion at University Hospital Düsseldorf from 2019 onward (prospective cohort) •- Written informed consent for participation in the registry (prospective part only)
排除标准
- •< 18 years
- •Lack of written informed consent
- •Pregnancy
结局指标
主要结局
Periprocedural and postprocedural safety events
时间窗: Up to 24 months after procedure
All cardiovascular adverse events or complications occurring during hospitalization and late complications after discharge related to EPS, ablation, or electrical cardioversion.
Clinical efficacy outcomes
时间窗: Up to 24 months after procedure
Procedural success, recurrence of arrhythmias or symptoms, and need for repeat EPS/cardioversion, additional medication, or device implantation (e.g., pacemaker).
次要结局
- All-cause mortality(Up to 24 months after procedure)
- All-cause hospitalization(Up to 24 months after procedure)