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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
437

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
12-lead ECG
Time Frame: 4 weeks
Presence of sinus rhythm on ECG
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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