Atrial FibrillationNCT05995561
HERA FIb Registry for Patients With Atrial Fibrillation
An observational study of Atrial Fibrillation, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The single-center HERA AFIb registry was created to assess real-world prevalence, demographic characteristics and management of patients with atrial fibrillation (AF) in the era of novel oral anticoagulant regimes (NOAC) presenting in the emergency department (ED) of University of Heidelberg Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 12,297 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2009to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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: A cohort of approximately 13000 consecutive patients with atrial fibrillation presenting to the emergency department of the Heidelberg University Hospital.
Who may be able to join
- documented atrial fibrillation
- availability of at least one hsTnT measurement
Who cannot join
- lost to follow-up
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: Heidelberg Registry of Atrial Fibrillation
The single-center HERA AFIb registry was created to assess real-world prevalence, demographic characteristics and management of patients with atrial fibrillation (AF) in the era of novel oral anticoagulant regimes (NOAC) presenting in the emergency department (ED) of University of Heidelberg
Read the detailed description
HERA AFIb is a single-center retrospective registry which enrolled consecutive cases presenting with atrial fibrillation at the emergency department of University Hospital of Heidelberg. Clinical parameters and characteristics for cases were assessed retrospectively. Follow-up was performed via review of medical reports, phone calls and postal queries. Outcome parameters included rates for all-cause mortality, non-hemorrhagic stroke, myocardial infarction and major bleeding.
- Conditions
- Atrial Fibrillation
- Being tested
- no intervention is planned.
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention is planned.Other
no intervention is planned.
| Study group | Role | What they receive |
|---|---|---|
| atrial fibrillation | cases presenting with atrial fibrillation at the emegency department. Receives: Other: no intervention is planned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
all-cause mortality during follow-up
Measured: 24 months
Secondary outcomes (3)
ischaemic stroke
ischaemic stroke during follow-up
Measured: 24 months
major bleeding
major bleeding during follow-up
Measured: 24 months
myocardial infarction
myocardial infarction during follow-up
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Jun 2009
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 12,297 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Yildirim, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995561
- Sponsor's protocol ID
- HERA FIb registry
- Status last verified
- May 2024
- First submitted
- 8 Aug 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yildirim M, Salbach C, Durr J, Mueller-Hennessen M, Katus HA, Frey N, Giannitsis E. Type 1 and type 2 NSTEMI in atrial fibrillation: insights from the HERA-FIB registry. Clin Res Cardiol. 2026 Apr 15. doi: 10.1007/s00392-026-02912-8. Online ahead of print.
PubMed 41984154Salbach C, Yildirim M, Hund H, Muller-Hennessen M, Frey N, Katus HA, Giannitsis E, Milles BR. Effect of non-invasive rhythm control on outcomes in patients with first diagnosed atrial fibrillation presenting to an emergency department. BMC Emerg Med. 2025 Mar 3;25(1):35. doi: 10.1186/s12873-025-01194-z.
PubMed 40033211Yildirim M, Milles BR, Hund H, Biener M, Muller-Hennessen M, Frey N, Katus HA, Giannitsis E, Salbach C. Outcomes and Disease Management in Patients With Atrial Fibrillation >/=80 Years: Data From a Consecutive 11-Year Real-World Registry. J Am Heart Assoc. 2025 Feb 18;14(4):e036832. doi: 10.1161/JAHA.124.036832. Epub 2025 Feb 8.
PubMed 39921512Salbach C, Yildirim M, Hund H, Biener M, Muller-Hennessen M, Frey N, Katus HA, Giannitsis E, Milles BR. Design, Rationale and Initial Findings From HERA-FIB on 10 222 Patients With Atrial Fibrillation Presenting to an Emergency Department Over An 11-Year Period. J Am Heart Assoc. 2024 May 7;13(9):e033396. doi: 10.1161/JAHA.123.033396. Epub 2024 Apr 19.
PubMed 38639359
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heidelberg Registry of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05995561
- Acronym / sponsor ID
- HERA FIb registry
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,297 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Jun 2009 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 16 Aug 2023 (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.
The single-center HERA AFIb registry was created to assess real-world prevalence, demographic characteristics and management of patients with atrial fibrillation (AF) in the era of novel oral anticoagulant regimes (NOAC) presenting in the emergency department (ED) of University of Heidelberg
Detailed description
HERA AFIb is a single-center retrospective registry which enrolled consecutive cases presenting with atrial fibrillation at the emergency department of University Hospital of Heidelberg. Clinical parameters and characteristics for cases were assessed retrospectively. Follow-up was performed via review of medical reports, phone calls and postal queries. Outcome parameters included rates for all-cause mortality, non-hemorrhagic stroke, myocardial infarction and major bleeding.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| atrial fibrillation | – | Other: no intervention is planned.cases presenting with atrial fibrillation at the emegency department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of approximately 13000 consecutive patients with atrial fibrillation presenting to the emergency department of the Heidelberg University Hospital.
Key inclusion criteria (2 listed)
- documented atrial fibrillation
- availability of at least one hsTnT measurement
Key exclusion criteria (1 listed)
- lost to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention is planned.no intervention is planned. | Other | atrial fibrillation |
Primary outcome
all-cause mortality
Time frame: 24 months
all-cause mortality during follow-up
3 secondary outcomes
ischaemic stroke
Time frame: 24 months
major bleeding
Time frame: 24 months
myocardial infarction
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 41984154Yildirim M, Salbach C, Durr J, Mueller-Hennessen M, Katus HA, Frey N, Giannitsis E. Type 1 and type 2 NSTEMI in atrial fibrillation: insights from the HERA-FIB registry. Clin Res Cardiol. 2026 Apr 15. doi: 10.1007/s00392-026-02912-8. Online ahead of print.
- Derived from this study: PubMed 40033211Salbach C, Yildirim M, Hund H, Muller-Hennessen M, Frey N, Katus HA, Giannitsis E, Milles BR. Effect of non-invasive rhythm control on outcomes in patients with first diagnosed atrial fibrillation presenting to an emergency department. BMC Emerg Med. 2025 Mar 3;25(1):35. doi: 10.1186/s12873-025-01194-z.
- Derived from this study: PubMed 39921512Yildirim M, Milles BR, Hund H, Biener M, Muller-Hennessen M, Frey N, Katus HA, Giannitsis E, Salbach C. Outcomes and Disease Management in Patients With Atrial Fibrillation >/=80 Years: Data From a Consecutive 11-Year Real-World Registry. J Am Heart Assoc. 2025 Feb 18;14(4):e036832. doi: 10.1161/JAHA.124.036832. Epub 2025 Feb 8.
- Derived from this study: PubMed 38639359Salbach C, Yildirim M, Hund H, Biener M, Muller-Hennessen M, Frey N, Katus HA, Giannitsis E, Milles BR. Design, Rationale and Initial Findings From HERA-FIB on 10 222 Patients With Atrial Fibrillation Presenting to an Emergency Department Over An 11-Year Period. J Am Heart Assoc. 2024 May 7;13(9):e033396. doi: 10.1161/JAHA.123.033396. Epub 2024 Apr 19.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by University Hospital Heidelberg 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 1 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: finished, as of the sponsor's last update on 9 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05995561, which also lists 4 linked publications.
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 9 May 2024.