NCT05995561

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12,297

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 1, 2009

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

10.8 years

First QC Date

August 8, 2023

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality

    all-cause mortality during follow-up

    24 months

Secondary Outcomes (3)

  • ischaemic stroke

    24 months

  • major bleeding

    24 months

  • myocardial infarction

    24 months

Study Arms (1)

atrial fibrillation

cases presenting with atrial fibrillation at the emegency department.

Other: no intervention is planned.

Interventions

no intervention is planned.

atrial fibrillation

Eligibility Criteria

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

A cohort of approximately 13000 consecutive patients with atrial fibrillation presenting to the emergency department of the Heidelberg University Hospital.

You may qualify if:

  • documented atrial fibrillation
  • availability of at least one hsTnT measurement

You may not qualify if:

  • lost to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (3)

  • Salbach 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.

  • Yildirim 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.

  • Salbach 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.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 16, 2023

Study Start

June 1, 2009

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations