The objective is to compare IV vernakalant to IV procainamide for the ED management of acute AF patients. If vernakalant proves to be more effective, faster, and safer than IV procainamide, this will give clinicians an important alternative for pharmacological cardioversion of acute AF. The investigators propose a pragmatic comparative effectiveness trial entailing an open label, randomized controlled trial at 12 large Canadian EDs. Study subjects will be randomized to 1 of 2 treatment arms: 1) Patients will receive an initial infusion of 3mg/kg of IV vernakalant over 10 minutes, followed by a second dose of 2mg/kg over 10 minutes, if necessary, or 2) Patients will receive a continuous infusion of 15mg/kg of IV procainamide over 60 minutes. The primary aim will be to compare conversion to normal sinus rhythm between the two drugs. The investigators will include stable patients presenting with an episode of acute AF of at least 3 hours duration, where symptoms require urgent management and where immediate cardioversion is a reasonable option. Using the integrated consent model, research assistants will obtain verbal consent from eligible patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
an initial infusion of 3 mg/kg infused over a 10-minute period by a pre-programmed IV pump
15 mg/kg in 500 mL of normal saline given over 60 minutes
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
St. Michaels
Toronto, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Laval, Quebec, Canada
...and 4 more locations
Conversion to sinus rhythm for a minimum duration of 30 minutes
Conversion to and maintenance of sinus rhythm for at least 30 minutes at any time following randomization until 30 minutes past the completion of the drug infusion. Heart rhythm will be determined by an electrocardiogram (ECG).
Time frame: During any time following randomization until 30 minutes past the completion of the drug infusion
Normal sinus rhythm
Being in normal sinus rhythm at the time of ED disposition (discharge or admission). Heart rhythm will be determined by an electrocardiogram (ECG).
Time frame: At the time of patient disposition (approximately 3 hours after arrival)
Patient disposition (admission or discharge)
Whether the patient was discharged home or admitted to the hospital.
Time frame: At the time of patient admission or discharge (approximately 3 hours after arrival)
Length of stay in ED
Length of stay in ED in minutes, from time of arrival to time of discharge or admission
Time frame: From time of arrival until time of discharge or admission (approximately 3 hours)
Time to discharge
Time to discharge in minutes, from time of randomization to time of discharge or admission
Time frame: From time of randomization until time of discharge or admission (approximately 3 hours)
Time to conversion
Time to conversion to sinus rhythm in minutes, from time of start of study drug infusion
Time frame: From time of infusion start until time of conversion to sinus rhythm (approximately 0 - 90 minutes)
Whether the patient required electrical cardioversion
Whether the patient required electrical cardioversion to restore normal sinus rhythm in the ED
Time frame: From 30 minutes after the study drug infusion is completed.
Adverse events
will be classified as serious or other, whether occurring 0-2 hours or 2-12 hours after infusion, whether infusion had to be halted or discontinued, or treatment required
Time frame: 0-12 hours
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