Atrial Fibrillation (AF)NCT07196176
Electrophysiological Registry Duesseldorf
An observational study of Atrial Fibrillation (AF) and Atrial Flutter, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Flutter, Supraventricular Tachycardias
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2019to 31 Dec 2031
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with heart rhythm disorders
Who may be able to join
- 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)
Who cannot join
- < 18 years
- Lack of written informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Duesseldorf
Düsseldorf, 40225
02118105187, saskia.pietrucha@med.uni-duesseldorf.de
About this study
Official title: Registry on Electrophysiological Studies (EPS) at University Hospital Düsseldorf
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.
Read the 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)
- Keywords
- atrial fibrillation, catheter ablation, cardioversion
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Tachycardia, Supraventricular, Tachycardia, Ventricular
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Up to 24 months after procedure
Secondary outcomes (2)
All-cause mortality
Death from any cause during follow-up.
Measured: Up to 24 months after procedure
All-cause hospitalization
Any hospital admission for cardiovascular or non-cardiovascular reasons during follow-up
Measured: Up to 24 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Jun 2019
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malte Kelm, MD, Study chair, Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital DuesseldorfObaida Rana, MD, Principal investigator, Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196176
- Sponsor's protocol ID
- EPS Registry
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not necessary as its a registry
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry on Electrophysiological Studies (EPS) at University Hospital Düsseldorf
- ClinicalTrials.gov ID
- NCT07196176
- Acronym / sponsor ID
- EPS Registry
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter, Supraventricular Tachycardias, Ventricular Tachycardia (VT)
- Keywords
- atrial fibrillation, catheter ablation, cardioversion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart rhythm disorders
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- < 18 years
- Lack of written informed consent
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Periprocedural and postprocedural safety events
Time frame: 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
Time frame: 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).
2 secondary outcomes
All-cause mortality
Time frame: Up to 24 months after procedure
All-cause hospitalization
Time frame: Up to 24 months after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No. not necessary as its a registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malte Kelm, MD study chair
Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
Obaida Rana, MD principal investigator
Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Atrial Flutter, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Obaida Rana, MD (+492118118800, obaida.rana@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periprocedural and postprocedural safety events (time frame: Up to 24 months after procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.