NCT07196176

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
69mo left

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jun 2019Dec 2031

Study Start

First participant enrolled

June 1, 2019

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

11.6 years

First QC Date

September 17, 2025

Last Update Submit

September 26, 2025

Conditions

Keywords

atrial fibrillationcatheter ablationcardioversion

Outcome Measures

Primary Outcomes (2)

  • Periprocedural and postprocedural safety events

    All cardiovascular adverse events or complications occurring during hospitalization and late complications after discharge related to EPS, ablation, or electrical cardioversion.

    Up to 24 months after procedure

  • Clinical efficacy outcomes

    Procedural success, recurrence of arrhythmias or symptoms, and need for repeat EPS/cardioversion, additional medication, or device implantation (e.g., pacemaker).

    Up to 24 months after procedure

Secondary Outcomes (2)

  • All-cause mortality

    Up to 24 months after procedure

  • All-cause hospitalization

    Up to 24 months after procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with heart rhythm disorders

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Duesseldorf

Düsseldorf, 40225, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Atrial FibrillationAtrial FlutterTachycardia, SupraventricularTachycardia, Ventricular

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaCardiac Conduction System Disease

Study Officials

  • Malte Kelm, MD

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

    STUDY CHAIR
  • Obaida Rana, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2025

First Posted

September 29, 2025

Study Start

June 1, 2019

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

not necessary as its a registry

Locations