Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department
NCT ID: NCT02248753
Last Updated: 2020-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
437 participants
INTERVENTIONAL
2014-10-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Care
Pharmacological cardioversion and/or electrical cardioversion
Pharmacological cardioversion - Flecainide
Electrical cardioversion
Pharmacological cardioversion - Amiodarone
Wait-and-see Approach
Rate control drugs only (metoprolol, verapamil or digoxin)
Metoprolol
Verapamil
Digoxin
Interventions
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Pharmacological cardioversion - Flecainide
Electrical cardioversion
Metoprolol
Verapamil
Digoxin
Pharmacological cardioversion - Amiodarone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Harry J Crijns, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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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
Countries
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References
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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.
van 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.
Pluymaekers 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.
Other Identifiers
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837002524
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NL47065.068.13
Identifier Type: -
Identifier Source: org_study_id
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