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

NCT ID: NCT02248753

Last Updated: 2020-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

437 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Care

Pharmacological cardioversion and/or electrical cardioversion

Group Type ACTIVE_COMPARATOR

Pharmacological cardioversion - Flecainide

Intervention Type DRUG

Electrical cardioversion

Intervention Type PROCEDURE

Pharmacological cardioversion - Amiodarone

Intervention Type DRUG

Wait-and-see Approach

Rate control drugs only (metoprolol, verapamil or digoxin)

Group Type EXPERIMENTAL

Metoprolol

Intervention Type DRUG

Verapamil

Intervention Type DRUG

Digoxin

Intervention Type DRUG

Interventions

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Pharmacological cardioversion - Flecainide

Intervention Type DRUG

Electrical cardioversion

Intervention Type PROCEDURE

Metoprolol

Intervention Type DRUG

Verapamil

Intervention Type DRUG

Digoxin

Intervention Type DRUG

Pharmacological cardioversion - Amiodarone

Intervention Type DRUG

Other Intervention Names

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Flecainide Tambocor Selokeen Isoptin Lanoxin Amiodarone Cordarone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harry J Crijns, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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VU University Medical Center

Amsterdam, , Netherlands

Site Status

Amphia Hospital

Breda, , Netherlands

Site Status

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

Medisch Spectrum Twente

Enschede, , Netherlands

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

Zuyderland Medical Center

Heerlen, , Netherlands

Site Status

Alrijne Hospital

Leiderdorp, , Netherlands

Site Status

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

St. Antonius Hospital

Nieuwegein, , Netherlands

Site Status

Franciscus Gasthuis

Rotterdam, , Netherlands

Site Status

Antonius Ziekenhuis

Sneek, , Netherlands

Site Status

HagaZiekenhuis

The Hague, , Netherlands

Site Status

St. Elisabeth - TweeSteden Hospital

Tilburg, , Netherlands

Site Status

Diakonessenhuis

Utrecht, , Netherlands

Site Status

VieCuri Medical Center

Venlo, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 27979041 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36322782 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30883054 (View on PubMed)

Other Identifiers

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837002524

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL47065.068.13

Identifier Type: -

Identifier Source: org_study_id

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