Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department
RACE 7 ACWAS
2 other identifiers
interventional
437
1 country
15
Brief Summary
A symptomatic episode of the heart rhythm disorder 'atrial fibrillation' (AF) is a frequent reason for visits to the emergency department. Currently, in the majority of cases, immediate (electrical or pharmacological) cardioversion is chosen, while atrial fibrillation terminates spontaneously in 70% of the cases within 24 hours. A wait-and-see approach with rate-control medication only, and when needed cardioversion within 48 hours of onset of symptoms, could be effective, safe and more cost-effective than current standard of care and could lead to a higher quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started Oct 2014
Longer than P75 for not_applicable atrial-fibrillation
15 active sites
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
September 16, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJanuary 21, 2020
January 1, 2020
4.1 years
September 16, 2014
January 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
12-lead ECG
Presence of sinus rhythm on ECG
4 weeks
Secondary Outcomes (6)
Time to conversion to sinus rhythm (Holter monitor)
48 hours
Quality of life (SF-36)
Baseline, 4 weeks, 6 months, 12 months
One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events
One year
Time to first recurrence of Atrial Fibrillation
1 month
Total health care and societal costs
1 year
- +1 more secondary outcomes
Study Arms (2)
Standard Care
ACTIVE COMPARATORPharmacological cardioversion and/or electrical cardioversion
Wait-and-see Approach
EXPERIMENTALRate control drugs only (metoprolol, verapamil or digoxin)
Interventions
Eligibility Criteria
You may qualify if:
- ECG with atrial fibrillation at the emergency department
- Heart rate \> 70bpm
- Symptoms most probable due to atrial fibrillation
- Duration of symptoms \< 36 hours
- \> 18 years of age
- Able and willing to sign informed consent
- Able and willing to use MyDiagnostick
You may not qualify if:
- Signs of myocardial infarction on ECG
- Hemodynamic instability (systolic blood pressure \< 100mm Hg, heart rate \> 170 bpm)
- Presence of pre-excitation syndrome
- History of Sick Sinus Syndrome
- History of unexplained syncope
- History of persistent AF (episode of AF lasting more than 48 hours)
- Acute heart failure
- Currently enrolled in another clinical trial
- Deemed unsuitable for participation by attending physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
VU University Medical Center
Amsterdam, Netherlands
Amphia Hospital
Breda, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Zuyderland Medical Center
Heerlen, Netherlands
Alrijne Hospital
Leiderdorp, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Franciscus Gasthuis
Rotterdam, Netherlands
Antonius Ziekenhuis
Sneek, Netherlands
HagaZiekenhuis
The Hague, Netherlands
St. Elisabeth - TweeSteden Hospital
Tilburg, Netherlands
Diakonessenhuis
Utrecht, Netherlands
VieCuri Medical Center
Venlo, Netherlands
Related Publications (3)
Dudink E, Essers B, Holvoet W, Weijs B, Luermans J, Ramanna H, Liem A, van Opstal J, Dekker L, van Dijk V, Lenderink T, Kamp O, Kulker L, Rienstra M, Kietselaer B, Alings M, Widdershoven J, Meeder J, Prins M, van Gelder I, Crijns H. Acute cardioversion vs a wait-and-see approach for recent-onset symptomatic atrial fibrillation in the emergency department: Rationale and design of the randomized ACWAS trial. Am Heart J. 2017 Jan;183:49-53. doi: 10.1016/j.ahj.2016.09.009. Epub 2016 Oct 2.
PMID: 27979041BACKGROUNDvan der Velden RMJ, Pluymaekers NAHA, Dudink EAMP, Luermans JGLM, Meeder JG, Heesen WF, Lenderink T, Widdershoven JWMG, Bucx JJJ, Rienstra M, Kamp O, van Opstal JM, Kirchhof CJHJ, van Dijk VF, Swart HP, Alings M, Van Gelder IC, Crijns HJGM, Linz D. Mobile health adherence for the detection of recurrent recent-onset atrial fibrillation. Heart. 2022 Dec 13;109(1):26-33. doi: 10.1136/heartjnl-2022-321346.
PMID: 36322782DERIVEDPluymaekers NAHA, Dudink EAMP, Luermans JGLM, Meeder JG, Lenderink T, Widdershoven J, Bucx JJJ, Rienstra M, Kamp O, Van Opstal JM, Alings M, Oomen A, Kirchhof CJ, Van Dijk VF, Ramanna H, Liem A, Dekker LR, Essers BAB, Tijssen JGP, Van Gelder IC, Crijns HJGM; RACE 7 ACWAS Investigators. Early or Delayed Cardioversion in Recent-Onset Atrial Fibrillation. N Engl J Med. 2019 Apr 18;380(16):1499-1508. doi: 10.1056/NEJMoa1900353. Epub 2019 Mar 18.
PMID: 30883054DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harry J Crijns, MD, PhD
Maastricht University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2014
First Posted
September 25, 2014
Study Start
October 1, 2014
Primary Completion
November 1, 2018
Study Completion
December 1, 2019
Last Updated
January 21, 2020
Record last verified: 2020-01