Atrial FibrillationRACE 7 ACWASNCT02248753
Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department
A study testing Pharmacological cardioversion - Flecainide, Electrical cardioversion and Metoprolol in people with Atrial Fibrillation, run by Maastricht University Medical Center at 15 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pharmacological cardioversion - Flecainide, Electrical cardioversion and Metoprolol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 437 participants
- Where
- 15 sitesNetherlands
- Study dates
- Oct 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Acute heart failure
- Currently enrolled in another clinical trial
- Deemed unsuitable for participation by attending physician
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Netherlands15 sites
VU University Medical Center
Amsterdam
Amphia Hospital
Breda
Catharina Ziekenhuis
Eindhoven
Medisch Spectrum Twente
Enschede
University Medical Center Groningen
Groningen
Zuyderland Medical Center
Heerlen
Alrijne Hospital
Leiderdorp
Maastricht University Medical Center
Maastricht
St. Antonius Hospital
Nieuwegein
Franciscus Gasthuis
Rotterdam
Antonius Ziekenhuis
Sneek
HagaZiekenhuis
The Hague
St. Elisabeth - TweeSteden Hospital
Tilburg
Diakonessenhuis
Utrecht
VieCuri Medical Center
Venlo
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Pharmacological cardioversion - Flecainide, Electrical cardioversion, Metoprolol, Verapamil, Digoxin
- Keywords
- Atrial fibrillation, Electrical cardioversion, Pharmacological cardioversion, Rhythm control, Rate control
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacological cardioversion - FlecainideDrug
Also called Flecainide, Tambocor
Electrical cardioversionProcedure or surgery
MetoprololDrug
Also called Selokeen
VerapamilDrug
Also called Isoptin
DigoxinDrug
Also called Lanoxin
Pharmacological cardioversion - AmiodaroneDrug
Also called Amiodarone, Cordarone
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Pharmacological cardioversion and/or electrical cardioversion Receives: Drug: Pharmacological cardioversion - Flecainide; Procedure: Electrical cardioversion; Drug: Pharmacological cardioversion - Amiodarone |
| Wait-and-see Approach | Experimental | Rate control drugs only (metoprolol, verapamil or digoxin) Receives: Drug: Metoprolol; Drug: Verapamil; Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-lead ECG
Presence of sinus rhythm on ECG
Measured: 4 weeks
Secondary outcomes (6)
Time to conversion to sinus rhythm (Holter monitor)
Intervention group only
Measured: 48 hours
Quality of life (SF-36)
Measured: Baseline, 4 weeks, 6 months, 12 months
One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events
Measured: One year
Time to first recurrence of Atrial Fibrillation
Monitoring through handheld device
Measured: 1 month
Total health care and societal costs
Measured: 1 year
Quality of Life (AFEQT)
Measured: Baseline, 4 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Harry J Crijns, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248753
- Sponsor's protocol ID
- NL47065.068.13
- Other IDs
- 837002524
- Acronym
- RACE 7 ACWAS
- Status last verified
- Jan 2020
- First submitted
- 16 Sep 2014
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27979041van 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.
PubMed 36322782Pluymaekers 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.
PubMed 30883054
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department (RACE 7 ACWAS-trial)
- ClinicalTrials.gov ID
- NCT02248753
- Acronym / sponsor ID
- RACE 7 ACWAS / NL47065.068.13
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Electrical cardioversion, Pharmacological cardioversion, Rhythm control, Rate control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Oct 2014 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Drug: Pharmacological cardioversion - Flecainide, Procedure: Electrical cardioversion, Drug: Pharmacological cardioversion - AmiodaronePharmacological cardioversion and/or electrical cardioversion |
| Wait-and-see Approach | Experimental | Drug: Metoprolol, Drug: Verapamil, Drug: DigoxinRate control drugs only (metoprolol, verapamil or digoxin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacological cardioversion - FlecainideAlso: Flecainide, Tambocor | Drug | Standard Care |
| Electrical cardioversion | Procedure or surgery | Standard Care |
| MetoprololAlso: Selokeen | Drug | Wait-and-see Approach |
| VerapamilAlso: Isoptin | Drug | Wait-and-see Approach |
| DigoxinAlso: Lanoxin | Drug | Wait-and-see Approach |
| Pharmacological cardioversion - AmiodaroneAlso: Amiodarone, Cordarone | Drug | Standard Care |
Primary outcome
12-lead ECG
Time frame: 4 weeks
Presence of sinus rhythm on ECG
6 secondary outcomes
Time to conversion to sinus rhythm (Holter monitor)
Time frame: 48 hours
Quality of life (SF-36)
Time frame: Baseline, 4 weeks, 6 months, 12 months
One-year follow-up of Major Adverse Cerebrovascular or Cardiovascular Events
Time frame: One year
Time to first recurrence of Atrial Fibrillation
Time frame: 1 month
Total health care and societal costs
Time frame: 1 year
Quality of Life (AFEQT)
Time frame: Baseline, 4 weeks, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Background: PubMed 27979041Dudink 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.
- Derived from this study: PubMed 36322782van 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.
- Derived from this study: PubMed 30883054Pluymaekers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry J Crijns, MD, PhD principal investigator
Maastricht University Medical Center
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacological cardioversion - Flecainide, Electrical cardioversion and Metoprolol in people with Atrial Fibrillation, run by Maastricht University Medical Center at 15 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-lead ECG (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02248753, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020; AzTrials last refreshed its copy on 31 Oct 2026.