Electrophysiological Registry Duesseldorf

NCT ID: NCT07196176

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2031-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Atrial Fibrillation (AF); Atrial Flutter; Supraventricular Tachycardias; Ventricular Tachycardia (VT)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• < 18 years
• Lack of written informed consent
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malte Kelm, MD

Role: STUDY_CHAIR

Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf

Obaida Rana, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf

Locations

University Hospital Duesseldorf

Düsseldorf, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Obaida Rana, MD

Role: CONTACT

obaida.rana@med.uni-duesseldorf.de

+492118118800

Lisa Dannenberg, MD

Role: CONTACT

LisaKristina.Dannenberg@med.uni-duesseldorf.de

+ 49211 81 05315

Facility Contacts

Role: primary

saskia.pietrucha@med.uni-duesseldorf.de

02118105187

Other Identifiers

EPS Registry

Identifier Type: -

Identifier Source: org_study_id