HERA FIb Registry for Patients With Atrial Fibrillation | NCT05995561

Studies
HERA FIb Registry for Patients With Atrial Fibrillation

NCT05995561

Sponsor

University Hospital Heidelberg

Status

Completed

Last Update Posted

May 9, 2024Actual

Enrollment

12,297Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

no intervention is planned.

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2009Actual

Primary Completion Date

Apr 1, 2020Actual

Completion Date

Apr 1, 2020Actual

First Submitted Date

Aug 8, 2023

First Submission Date that Met QC Criteria

Aug 8, 2023

First Posted Date

Aug 16, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2024

Last Update Posted Date

May 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mustafa Yildirim, Principle investigator, University Hospital HeidelbergPrincipal Investigator

Lead Sponsor

University Hospital HeidelbergOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12,297Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
atrial fibrillation		cases presenting with atrial fibrillation at the emegency department.	Other: no intervention is planned.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention is planned.	Other	no intervention is planned.	atrial fibrillation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all-cause mortality	all-cause mortality during follow-up	24 months

Secondary Outcomes

Measure	Description	Time Frame
ischaemic stroke	ischaemic stroke during follow-up	24 months
major bleeding	major bleeding during follow-up	24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

documented atrial fibrillation
availability of at least one hsTnT measurement

Exclusion Criteria:

lost to follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Heidelberg		Heidelberg	Baden-Wurttemberg	69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41984154	Derived	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.
40033211	Derived	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.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes