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

January 17, 2020 updated by: Maastricht University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

437

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • VU University Medical Center
      • Breda, Netherlands
        • Amphia Hospital
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Groningen, Netherlands
        • University Medical Center Groningen
      • Heerlen, Netherlands
        • Zuyderland Medical Center
      • Leiderdorp, Netherlands
        • Alrijne Hospital
      • Maastricht, Netherlands
        • Maastricht University Medical Center
      • Nieuwegein, Netherlands
        • St. Antonius Hospital
      • Rotterdam, Netherlands
        • Franciscus Gasthuis
      • Sneek, Netherlands
        • Antonius Ziekenhuis
      • The Hague, Netherlands
        • Hagaziekenhuis
      • Tilburg, Netherlands
        • St. Elisabeth - TweeSteden Hospital
      • Utrecht, Netherlands
        • Diakonessenhuis
      • Venlo, Netherlands
        • VieCuri Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard Care
Pharmacological cardioversion and/or electrical cardioversion
Drug: Pharmacological cardioversion - Flecainide
Other Names:
  • Tambocor
  • Flecainide
Procedure: Electrical cardioversion
Drug: Pharmacological cardioversion - Amiodarone
Other Names:
  • Cordarone
  • Amiodarone
EXPERIMENTAL: Wait-and-see Approach
Rate control drugs only (metoprolol, verapamil or digoxin)
Drug: Verapamil
Other Names:
  • Isoptin
Drug: Metoprolol
Other Names:
  • Selokeen
Drug: Digoxin
Other Names:
  • Lanoxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12-lead ECG
Time Frame: 4 weeks
Presence of sinus rhythm on ECG
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to conversion to sinus rhythm (Holter monitor)
Time Frame: 48 hours
Intervention group only
48 hours
Quality of life (SF-36)
Time Frame: Baseline, 4 weeks, 6 months, 12 months
Baseline, 4 weeks, 6 months, 12 months
One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events
Time Frame: One year
One year
Time to first recurrence of Atrial Fibrillation
Time Frame: 1 month
Monitoring through handheld device
1 month
Total health care and societal costs
Time Frame: 1 year
1 year
Quality of Life (AFEQT)
Time Frame: Baseline, 4 weeks, 6 months, 12 months
Baseline, 4 weeks, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Harry J Crijns, MD, PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2014

Primary Completion (ACTUAL)

November 1, 2018

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 22, 2014

First Posted (ESTIMATE)

September 25, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL47065.068.13
  • 837002524 (OTHER_GRANT: ZonMw)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Verapamil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe