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

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Metoprolol; Drug: Pharmacological cardioversion - Amiodarone; Procedure: Electrical cardioversion; Drug: Verapamil; Drug: Pharmacological cardioversion - Flecainide; Drug: Digoxin

Study type: Interventional

Funder types: Other

Identifiers

NCT02248753

837002524 (Other Grant/Funding Number)

NL47065.068.13

Details and patient eligibility

About

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.

Enrollment: 437 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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437 participants in 2 patient groups

Standard Care

Active Comparator group

Description:

Pharmacological cardioversion and/or electrical cardioversion

Treatment:

Procedure: Electrical cardioversion

Drug: Pharmacological cardioversion - Flecainide

Drug: Pharmacological cardioversion - Amiodarone

Wait-and-see Approach

Experimental group

Description:

Rate control drugs only (metoprolol, verapamil or digoxin)

Treatment:

Drug: Digoxin

Drug: Verapamil

Drug: Metoprolol