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Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department

Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department (RACE 7 ACWAS-trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02248753
Acronym
RACE 7 ACWAS
Enrollment
437
Registered
2014-09-25
Start date
2014-10-31
Completion date
2019-12-31
Last updated
2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Electrical cardioversion, Pharmacological cardioversion, Rhythm control, Rate control

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.

Interventions

DRUGPharmacological cardioversion - Flecainide
DRUGMetoprolol
DRUGVerapamil
DRUGDigoxin
DRUGPharmacological cardioversion - Amiodarone

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
12-lead ECG4 weeksPresence of sinus rhythm on ECG

Secondary

MeasureTime frameDescription
Time to conversion to sinus rhythm (Holter monitor)48 hoursIntervention group only
Quality of life (SF-36)Baseline, 4 weeks, 6 months, 12 months
Quality of Life (AFEQT)Baseline, 4 weeks, 6 months, 12 months
Time to first recurrence of Atrial Fibrillation1 monthMonitoring through handheld device
Total health care and societal costs1 year
One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular EventsOne year

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026