NCT03272620

Brief Summary

The results of this study could imply that a atrial fibrillation registry, as a tool for structured diagnosis and therapy in patients with atrial fibrillation, may improve patient care for this rapidly growing population.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress76%
Oct 2014Jan 2030

Study Start

First participant enrolled

October 22, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Expected
Last Updated

September 5, 2017

Status Verified

September 1, 2017

Enrollment Period

5.2 years

First QC Date

August 23, 2017

Last Update Submit

September 1, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with major adverse cardiac events

    frequency distribution

    Follow up (10 years)

Secondary Outcomes (1)

  • Number of successfully conducted cardioversions

    Follow up (10 years)

Eligibility Criteria

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

Patients with atrial fibrillation treated at the Emergency Department of the Vienna Medical University. Currently, about 600 patients with atrial fibrillation are seen annually at the Emergency Department, every patient with atrial fibrillation treated at the Emergency Department should be included.

You may qualify if:

  • Patients with atrial fibrillation treated at the Emergency Department of the Medical University of Vienna
  • Signed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Department, Medical University Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (16)

  • Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.

    PMID: 11343485BACKGROUND
  • Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials. Arch Intern Med. 1994 Jul 11;154(13):1449-57.

    PMID: 8018000BACKGROUND
  • Lip GY, Tean KN, Dunn FG. Treatment of atrial fibrillation in a district general hospital. Br Heart J. 1994 Jan;71(1):92-5. doi: 10.1136/hrt.71.1.92.

    PMID: 8297706BACKGROUND
  • Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.

    PMID: 9737513BACKGROUND
  • O'Reilly DJ, Hopkins RB, Healey JS, Dorian P, Sauriol L, Tarride JE, Burke N, Goeree RA. The burden of atrial fibrillation on the hospital sector in Canada. Can J Cardiol. 2013 Feb;29(2):229-35. doi: 10.1016/j.cjca.2012.03.023. Epub 2012 May 30.

    PMID: 22652091BACKGROUND
  • Domanovits H, Schillinger M, Thoennissen J, Nikfardjam M, Janata K, Brunner M, Laggner AN. Termination of recent-onset atrial fibrillation/flutter in the emergency department: a sequential approach with intravenous ibutilide and external electrical cardioversion. Resuscitation. 2000 Aug 1;45(3):181-7. doi: 10.1016/s0300-9572(00)00180-5.

    PMID: 10959017BACKGROUND
  • Vinson DR, Hoehn T, Graber DJ, Williams TM. Managing emergency department patients with recent-onset atrial fibrillation. J Emerg Med. 2012 Feb;42(2):139-48. doi: 10.1016/j.jemermed.2010.05.017. Epub 2010 Jul 15.

    PMID: 20634022BACKGROUND
  • von Besser K, Mills AM. Is discharge to home after emergency department cardioversion safe for the treatment of recent-onset atrial fibrillation? Ann Emerg Med. 2011 Dec;58(6):517-20. doi: 10.1016/j.annemergmed.2011.06.014. Epub 2011 Jul 29.

    PMID: 22098994BACKGROUND
  • Bellone A, Etteri M, Vettorello M, Bonetti C, Clerici D, Gini G, Maino C, Mariani M, Natalizi A, Nessi I, Rampoldi A, Colombo L. Cardioversion of acute atrial fibrillation in the emergency department: a prospective randomised trial. Emerg Med J. 2012 Mar;29(3):188-91. doi: 10.1136/emj.2010.109702. Epub 2011 Mar 21.

    PMID: 21422032BACKGROUND
  • Hochtl T, Huber K. New anticoagulants for the prevention of stroke in atrial fibrillation. Fundam Clin Pharmacol. 2012 Feb;26(1):47-53. doi: 10.1111/j.1472-8206.2011.00982.x. Epub 2011 Aug 29.

    PMID: 21883447BACKGROUND
  • Oldgren J, Healey JS, Ezekowitz M, Commerford P, Avezum A, Pais P, Zhu J, Jansky P, Sigamani A, Morillo CA, Liu L, Damasceno A, Grinvalds A, Nakamya J, Reilly PA, Keltai K, Van Gelder IC, Yusufali AH, Watanabe E, Wallentin L, Connolly SJ, Yusuf S; RE-LY Atrial Fibrillation Registry Investigators. Variations in cause and management of atrial fibrillation in a prospective registry of 15,400 emergency department patients in 46 countries: the RE-LY Atrial Fibrillation Registry. Circulation. 2014 Apr 15;129(15):1568-76. doi: 10.1161/CIRCULATIONAHA.113.005451. Epub 2014 Jan 24.

    PMID: 24463370BACKGROUND
  • Rovellini A, Folli C, Cardani F, Monzani V. Thromboembolic and haemorrhagic events in permanent atrial fibrillation: observational study in an emergency department. Eur J Intern Med. 2009 Dec;20(8):756-9. doi: 10.1016/j.ejim.2009.08.008. Epub 2009 Sep 24.

    PMID: 19892303BACKGROUND
  • Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines-CPG; Document Reviewers. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation--developed with the special contribution of the European Heart Rhythm Association. Europace. 2012 Oct;14(10):1385-413. doi: 10.1093/europace/eus305. Epub 2012 Aug 24. No abstract available.

    PMID: 22923145BACKGROUND
  • Niederdockl JD, Simon A, Buchtele N, Schutz N, Cacioppo F, Oppenauer J, Gupta S, Lutnik M, Schnaubelt S, Spiel A, Roth D, Wimbauer F, Fegers-Wustrow I, Esefeld K, Halle M, Scharhag J, Laschitz T, Herkner H, Domanovits H, Schwameis M. Prediction of Successful Pharmacological Cardioversion in Acute Symptomatic Atrial Fibrillation: The Successful Intravenous Cardioversion for Atrial Fibrillation (SIC-AF) Score. J Pers Med. 2022 Mar 30;12(4):544. doi: 10.3390/jpm12040544.

  • Niederdockl J, Simon A, Cacioppo F, Buchtele N, Merrelaar A, Schutz N, Schnaubelt S, Spiel AO, Roth D, Schorgenhofer C, Herkner H, Domanovits H, Schwameis M. Predicting spontaneous conversion to sinus rhythm in symptomatic atrial fibrillation: The ReSinus score. Eur J Intern Med. 2021 Jan;83:45-53. doi: 10.1016/j.ejim.2020.07.022. Epub 2020 Sep 18.

  • Niederdockl J, Simon A, Schnaubelt S, Schuetz N, Laggner R, Sulzgruber P, Spiel AO, Herkner H, Laggner AN, Domanovits H. Cardiac biomarkers predict mortality in emergency patients presenting with atrial fibrillation. Heart. 2019 Mar;105(6):482-488. doi: 10.1136/heartjnl-2018-313145. Epub 2018 Nov 10.

MeSH Terms

Conditions

Atrial FibrillationAtrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Spiel, Priv. Doz.

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Niederdöckl, Dr.

CONTACT

Alexander Simon, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor at the Department of Emergency Medicine

Study Record Dates

First Submitted

August 23, 2017

First Posted

September 5, 2017

Study Start

October 22, 2014

Primary Completion

January 1, 2020

Study Completion (Estimated)

January 1, 2030

Last Updated

September 5, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations