NCT03344237

Brief Summary

The purpose of the Heidelberg Registry of Atrial Fibrillation (HERA-FIB) is to collect data on the prevalence and clinical significance of elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation presenting to an emergency department in the era of novel oral anticoagulants (NOACs).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 14, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

November 11, 2017

Last Update Submit

September 26, 2019

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

  • Vascular and non-vascular death

    Follow up after at least 6 months

  • Nonfatal myocardial infarction

    Follow up after at least 6 months

  • Stroke/systemic embolism

    Follow up after at least 6 months

Secondary Outcomes (1)

  • Stroke, systemic embolism, myocardial infarction, vascular death, non-vascular death, composite endpoint of vascular and non-vascular death, nonfatal MI, stroke/systemic embolism

    Follow up after at least 6 months

Other Outcomes (1)

  • Major bleeding by definition of International Society on Thrombosis and Haemostasis (ISTH)

    Follow up after at least 6 months

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A cohort of approximately 5000 consecutive patients with atrial fibrillation presenting to the emergency department of the Heidelberg University Hospital between March 2013 and June 2017

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Angiology and Pneumology, Heidelberg University Hospital

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mehrshad Vafaie, Dr.med.Dr.med.univ.

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehrshad Vafaie, Dr.med.Dr.med.univ.

CONTACT

00496221/56-8676mehrshad.vafaie@med.uni-heidelberg.de

Study Design

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

Study Record Dates

First Submitted

November 11, 2017

First Posted

November 17, 2017

Study Start

September 14, 2017

Primary Completion

November 1, 2019

Study Completion

March 1, 2020

Last Updated

September 27, 2019

Record last verified: 2019-09

Locations

DE(1)