AzTrials
AzTrials

Atrial FibrillationNCT03272620

Atrial Fibrillation at the Viennese University Emergency Department

An observational study of Atrial Fibrillation and Atrial Flutter, run by Medical University of Vienna at 1 site in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Atrial Flutter
How many people
3,000 participants
Where
1 siteAustria
Study dates
22 Oct 2014to 1 Jan 2030
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jan Niederdöckl, Dr. contact

jan.niederdöckl@meduniwien.ac.at

Alexander Simon, Dr. contact

alexander.simon@meduniwien.ac.at

Austria1 site, 1 recruiting

  • Emergency Department, Medical University Vienna

    Vienna, 1090

    Jan Niederdöckl, Dr., jan.niederdoeckl@medunwien.ac.at

    Alexander Simon, Dr., alexander.simon@medunwien.ac.at

    Recruiting

Other trials in Austria

About this study

Official title: Atrial Fibrillation Registry at the Emergency Department of the Medical University of Vienna: A Tool for Structured Diagnosis and Treatment

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.

Read the detailed description

Atrial fibrillation is the most common cardiac arrhythmia and is associated with increased cardiovascular morbidity and mortality, with stroke being an especially important and potentially devastating complication. The number of patients with atrial fibrillation is likely to increase 2.5-fold during the next 50 years, reflecting the growing proportion of elderly individuals. Emergency departments play a central role in diagnosis and treatment (rhythm and rate control, initiation of anticoagulatory therapy for stroke prevention) of atrial fibrillation. Additionally, embolic (e.g. stroke, mesenteric ischemia) complications of atrial fibrillation and bleeding complications (e.g. gastrointestinal and intracranial) of anticoagulatory therapy are likewise treated at emergency departments.

Therefor the investigators hypothesis implies that the atrial fibrillation registry could serve as a tool for structured diagnosis and therapy in patients with atrial fibrillation and therefore may improve patient care. Additionally, diagnostic and therapeutic shortcomings by analyzing registry data may be detected.

Medical subject headings
Atrial Fibrillation, Atrial Flutter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with major adverse cardiac events

    frequency distribution

    Measured: Follow up (10 years)

Secondary outcomes (1)

  1. Number of successfully conducted cardioversions

    frequency distribution

    Measured: Follow up (10 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2017
  2. Study start22 Oct 2014
  3. Primary completion1 Jan 2020 (estimated)
  4. Study completion1 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03272620
Sponsor's protocol ID
98765
Status last verified
Sep 2017
First submitted
23 Aug 2017
Last updated
5 Sep 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11343485

  • 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.

    PubMed 8018000

  • 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.

    PubMed 8297706

  • 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.

    PubMed 9737513

  • 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.

    PubMed 22652091

  • 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.

    PubMed 10959017

  • 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.

    PubMed 20634022

  • 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.

    PubMed 22098994

  • 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.

    PubMed 21422032

  • 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.

    PubMed 21883447

  • 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.

    PubMed 24463370

  • 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.

    PubMed 19892303

  • 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.

    PubMed 22923145

  • 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.

    PubMed 35455660

  • 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.

    PubMed 32951957

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Atrial Flutter, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jan Niederdöckl, Dr. (jan.niederdöckl@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with major adverse cardiac events (time frame: Follow up (10 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03272620, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in