HERA AFIb Registry for Patients With Atrial Fibrillation

HERA AFIb Registry

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: no intervention is planned.

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 Type: Observational
• Enrollment (Actual): 12297

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • University Hospital of Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• lost to follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
atrial fibrillation; cases presenting with atrial fibrillation at the emegency department.	Other: no intervention is planned.; no intervention is planned.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2009
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: HERA AFIb registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No