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

Atrial Fibrillation Clinical Trial

— RACE 7 ACWAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248753
• Other study ID #: NL47065.068.13
• Secondary ID: 837002524
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: December 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Emergencies

Intervention

Drug:
• Pharmacological cardioversion - Flecainide

Procedure:
• Electrical cardioversion

Drug:
• Metoprolol

• Verapamil

• Digoxin

• Pharmacological cardioversion - Amiodarone

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

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