search
Back to results

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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Pharmacological cardioversion - Flecainide
Electrical cardioversion
Metoprolol
Verapamil
Digoxin
Pharmacological cardioversion - Amiodarone
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Electrical cardioversion, Pharmacological cardioversion, Rhythm control, Rate control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VU University Medical Center
  • Amphia Hospital
  • Catharina Ziekenhuis
  • Medisch Spectrum Twente
  • University Medical Center Groningen
  • Zuyderland Medical Center
  • Alrijne Hospital
  • Maastricht University Medical Center
  • St. Antonius Hospital
  • Franciscus Gasthuis
  • Antonius Ziekenhuis
  • HagaZiekenhuis
  • St. Elisabeth - TweeSteden Hospital
  • Diakonessenhuis
  • VieCuri Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Care

Wait-and-see Approach

Arm Description

Pharmacological cardioversion and/or electrical cardioversion

Rate control drugs only (metoprolol, verapamil or digoxin)

Outcomes

Primary Outcome Measures

12-lead ECG
Presence of sinus rhythm on ECG

Secondary Outcome Measures

Time to conversion to sinus rhythm (Holter monitor)
Intervention group only
Quality of life (SF-36)
One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events
Time to first recurrence of Atrial Fibrillation
Monitoring through handheld device
Total health care and societal costs
Quality of Life (AFEQT)

Full Information

First Posted
September 16, 2014
Last Updated
January 17, 2020
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT02248753
Brief Title
Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department
Acronym
RACE 7 ACWAS
Official Title
Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department (RACE 7 ACWAS-trial)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Electrical cardioversion, Pharmacological cardioversion, Rhythm control, Rate control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
437 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Pharmacological cardioversion and/or electrical cardioversion
Arm Title
Wait-and-see Approach
Arm Type
Experimental
Arm Description
Rate control drugs only (metoprolol, verapamil or digoxin)
Intervention Type
Drug
Intervention Name(s)
Pharmacological cardioversion - Flecainide
Other Intervention Name(s)
Flecainide, Tambocor
Intervention Type
Procedure
Intervention Name(s)
Electrical cardioversion
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Other Intervention Name(s)
Selokeen
Intervention Type
Drug
Intervention Name(s)
Verapamil
Other Intervention Name(s)
Isoptin
Intervention Type
Drug
Intervention Name(s)
Digoxin
Other Intervention Name(s)
Lanoxin
Intervention Type
Drug
Intervention Name(s)
Pharmacological cardioversion - Amiodarone
Other Intervention Name(s)
Amiodarone, Cordarone
Primary Outcome Measure Information:
Title
12-lead ECG
Description
Presence of sinus rhythm on ECG
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Time to conversion to sinus rhythm (Holter monitor)
Description
Intervention group only
Time Frame
48 hours
Title
Quality of life (SF-36)
Time Frame
Baseline, 4 weeks, 6 months, 12 months
Title
One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events
Time Frame
One year
Title
Time to first recurrence of Atrial Fibrillation
Description
Monitoring through handheld device
Time Frame
1 month
Title
Total health care and societal costs
Time Frame
1 year
Title
Quality of Life (AFEQT)
Time Frame
Baseline, 4 weeks, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry J Crijns, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU University Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Amphia Hospital
City
Breda
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Facility Name
Zuyderland Medical Center
City
Heerlen
Country
Netherlands
Facility Name
Alrijne Hospital
City
Leiderdorp
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Facility Name
St. Antonius Hospital
City
Nieuwegein
Country
Netherlands
Facility Name
Franciscus Gasthuis
City
Rotterdam
Country
Netherlands
Facility Name
Antonius Ziekenhuis
City
Sneek
Country
Netherlands
Facility Name
HagaZiekenhuis
City
The Hague
Country
Netherlands
Facility Name
St. Elisabeth - TweeSteden Hospital
City
Tilburg
Country
Netherlands
Facility Name
Diakonessenhuis
City
Utrecht
Country
Netherlands
Facility Name
VieCuri Medical Center
City
Venlo
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
27979041
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.
Results Reference
background
PubMed Identifier
36322782
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.
Results Reference
derived
PubMed Identifier
30883054
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs