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Completed

NCT Number: NCT02248753

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VU University Medical Center, Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacological cardioversion - Flecainide

Drug

Other names: Flecainide, Tambocor

Electrical cardioversion

Procedure

metoprolol

Drug

Other names: Selokeen

Verapamil

Drug

Other names: Isoptin

Digoxin

Drug

Other names: Lanoxin

Pharmacological cardioversion - Amiodarone

Drug

Other names: Amiodarone, Cordarone

Primary outcomes

  1. 12-lead ECG

    Time frame: 4 weeks

    Presence of sinus rhythm on ECG

Secondary outcomes

  1. Time to conversion to sinus rhythm (Holter monitor)

    Time frame: 48 hours

    Intervention group only

  2. Quality of life (SF-36)

    Time frame: Baseline, 4 weeks, 6 months, 12 months

  3. One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events

    Time frame: One year

  4. Time to first recurrence of Atrial Fibrillation

    Time frame: 1 month

    Monitoring through handheld device

  5. Total health care and societal costs

    Time frame: 1 year

  6. Quality of Life (AFEQT)

    Time frame: Baseline, 4 weeks, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: RACE 7 ACWAS

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Sep 25, 2014
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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