Clinical trial NCT02248753: Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department
Official title: Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department (RACE 7 ACWAS-trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Electrical cardioversion
Pharmacological cardioversion
Rhythm control
Rate control
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2014-09-25
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 12-lead ECG
timeFrame: 4 weeks
Secondary outcomes:
measure: Time to conversion to sinus rhythm (Holter monitor)
timeFrame: 48 hours
measure: Quality of life (SF-36)
timeFrame: Baseline, 4 weeks, 6 months, 12 months
measure: One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events
timeFrame: One year
measure: Time to first recurrence of Atrial Fibrillation
timeFrame: 1 month
measure: Total health care and societal costs
timeFrame: 1 year
measure: Quality of Life (AFEQT)
timeFrame: Baseline, 4 weeks, 6 months, 12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Center
city: Leiderdorp
country: Netherlands
facility: Alrijne Hospital
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis
city: The Hague
country: Netherlands
facility: HagaZiekenhuis
city: Tilburg
country: Netherlands
facility: St. Elisabeth - TweeSteden Hospital
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Venlo
country: Netherlands
facility: VieCuri Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: Harry J Crijns, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.