NCT04476524

Brief Summary

Investigators developed a multidimensional protocol for the management of AF in the emergency department. Investigators aimed to assess if this new ER AF management protocol would result in better outcomes compared to routine care.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

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

First Submitted

Initial submission to the registry

July 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
26 days until next milestone

Study Start

First participant enrolled

August 15, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

July 14, 2020

Last Update Submit

February 2, 2021

Conditions

Cardiac ArrhythmiaAtrial Fibrillation

Keywords

Clinical and Economical impactTreatment pathwayEmergency RoomAtrial Fibrillation

Outcome Measures

Primary Outcomes (3)

  • Cumulative resource utilization in dollars

    Primary Outcome

    15 months

  • Time to definitive therapy (AAD and or Ablation)

    Primary Outcome

    15 months

  • Number of Hospital/clinic visits

    Primary Outcome

    15 months

Study Arms (2)

Study Arm

Patients who present with AF as the primary diagnosis to the ER will have their chart reviewed

Other: Quality improvement

Historical Cohort

Historical control arm will be selected from chart review of emergency department prior to the commencement of this study after propensity matching with age and sex.

Other: Quality improvement

Interventions

Quality improvementOTHER

All patients with AF as primary problem treated with study protocol would be compared with historical cohort of AF patients who were treated with routine care in the ER. Patients will be followed up and outcomes will be compared between two groups at 1, 3, 6 and 12 months.

Also known as: All patients with AF as primary problem treated with study protocol would be compared with historical cohort of AF patients who were treated with routine care in the ER.
Historical CohortStudy Arm

Eligibility Criteria

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

i) Study arm: Patients \> 18 years of age (both males and females) who present with AF as the primary diagnosis to the ER will have their chart reviewed. ii) Historical control arm:Historical control arm will be selected from chart review of emergency department prior to the commencement of this study after propensity matching with age and sex. All patients \> 18 years of age (both males and females) who presented with AF as primary diagnosis to the ER of the participating centers within last 2 years will be selected if they meet the inclusion/exclusion criteria mentioned below

You may qualify if:

  • Consecutive patients \> 18 years of age who comes to the ER with AF as the primary diagnosis and is treated according to study protocol.

You may not qualify if:

  • Patients with established cardiology or electrophysiology care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

RECRUITING

Related Publications (8)

  • Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.

    PMID: 24345399BACKGROUND

  • Savelieva I, Camm J. Update on atrial fibrillation: part I. Clin Cardiol. 2008 Feb;31(2):55-62. doi: 10.1002/clc.20138.

    PMID: 18257025BACKGROUND

  • Dagres N, Chao TF, Fenelon G, Aguinaga L, Benhayon D, Benjamin EJ, Bunch TJ, Chen LY, Chen SA, Darrieux F, de Paola A, Fauchier L, Goette A, Kalman J, Kalra L, Kim YH, Lane DA, Lip GYH, Lubitz SA, Marquez MF, Potpara T, Pozzer DL, Ruskin JN, Savelieva I, Teo WS, Tse HF, Verma A, Zhang S, Chung MK; ESC Scientific Document Group. European Heart Rhythm Association (EHRA)/Heart Rhythm Society (HRS)/Asia Pacific Heart Rhythm Society (APHRS)/Latin American Heart Rhythm Society (LAHRS) expert consensus on arrhythmias and cognitive function: what is the best practice? Europace. 2018 Sep 1;20(9):1399-1421. doi: 10.1093/europace/euy046. No abstract available.

    PMID: 29562326BACKGROUND

  • Tse G, Lip GYH, Liu T. The CHADS2 and CHA2DS2-VASc scores for predicting healthcare utilization and outcomes: Observations on the Appropriate Use and Misuse of Risk scores. Int J Cardiol. 2017 Oct 15;245:181-182. doi: 10.1016/j.ijcard.2017.07.109. No abstract available.

    PMID: 28874290BACKGROUND

  • Rozen G, Hosseini SM, Kaadan MI, Biton Y, Heist EK, Vangel M, Mansour MC, Ruskin JN. Emergency Department Visits for Atrial Fibrillation in the United States: Trends in Admission Rates and Economic Burden From 2007 to 2014. J Am Heart Assoc. 2018 Jul 20;7(15):e009024. doi: 10.1161/JAHA.118.009024.

    PMID: 30030215BACKGROUND

  • Scheuermeyer FX, Innes G, Pourvali R, Dewitt C, Grafstein E, Heslop C, MacPhee J, Ward J, Heilbron B, McGrath L, Christenson J. Missed opportunities for appropriate anticoagulation among emergency department patients with uncomplicated atrial fibrillation or flutter. Ann Emerg Med. 2013 Dec;62(6):557-565.e2. doi: 10.1016/j.annemergmed.2013.04.004. Epub 2013 May 24.

    PMID: 23711880BACKGROUND

  • Funk AM, Kocher KE, Rohde JM, West BT, Crawford TC, Froehlich JB, Saberi S. Variation in practice patterns among specialties in the acute management of atrial fibrillation. BMC Cardiovasc Disord. 2015 Mar 12;15:21. doi: 10.1186/s12872-015-0009-1.

    PMID: 25880061BACKGROUND

  • Rogenstein C, Kelly AM, Mason S, Schneider S, Lang E, Clement CM, Stiell IG. An international view of how recent-onset atrial fibrillation is treated in the emergency department. Acad Emerg Med. 2012 Nov;19(11):1255-60. doi: 10.1111/acem.12016.

    PMID: 23167856BACKGROUND

MeSH Terms

Conditions

Arrhythmias, CardiacAtrial FibrillationEmergencies

Interventions

Quality Improvement

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

EngineeringTechnology, Industry, and AgricultureQuality of Health CareHealth Services Administration

Study Officials

  • Dhanunjaya Lakkireddy

    Kansas City Heart Rhythm Research Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969datkins@kchrf.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 20, 2020

Study Start

August 15, 2020

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

February 4, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)