About this trial
Post-operative atrial fibrillation is a common problem post cardiac surgery with rates exceeding 30%. Atrial fibrillation has multiple adverse effects on cardiac hemodynamics and can lead to hypotension, diminished end organ perfusion and lengthen the stay in ICU. Amiodarone is the medication of choice used for pharmacological cardioversion and can be used with vasoactive medications. Intravenous amiodarone is associated with hypotension and end organ perfusion requiring escalation in vasoactive support. Vernakalant is novel anti-arrhythmic agent approved in Canada for cardioversion of atrial fibrillation that primarily works on atrial channels and has no effect on contractility or vasodilation. Clinical trials have proved good efficacy of Vernakalant in conversion of paroxysmal atrial fibrillation however there is no comparison of Amiodarone to Vernakalant in post-operative cardiac surgery. We plan to perform a clinical trial comparing Vernakalant to amiodarone in post-cardiac surgery patients with a primary outcome of cardioversion at 90 minutes. Secondary outcomes will follow duration of vasoactive medications, days in ICU and economics.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >/=18 years
Undergone heart surgery for coronary artery bypass surgery (on-pump or off-pump CABG) and/or valve repair or replacement (excluding mechanical valves), including re-operations.
Hemodynamically stable with/without vasopressor support
Disqualifiers
LVAD insertion or heart transplantation
MAZE procedure
Transcatheter aortic valve replacement (TAVR)
History of or planned mechanical valve replacement
Trial design
Parallel
Treatments tested in this trial
Vernakalant
DrugPost operative AF after cardiac surgery. Vernakalant 3mg/kg over 10 minutes followed by 2mg/kg over 10 minutes if still in AF.
Amiodarone
DrugPost operative AF after cardiac surgery. Amiodarone 150mg IV followed by 1 mg/min x 6 hours then 0.5 mg/min x 12 hours
Treatment groups
Trial outcomes
Primary outcomes
Rate of conversion of sustained post-operative atrial fibrillation at 90 minutes.
Rate of conversion of sustained post-operative atrial fibrillation at 90 minutes.
Secondary outcomes
Duration of vasopressor therapy
Duration of vasopressor therapy
Time to conversion to sinus rhythm
Time to conversion to sinus rhythm
Days in intensive care unit
Days in intensive care unit
Recurrence of atrial fibrillation within 48 hours
Recurrence of atrial fibrillation within 48 hours
Locations
Sponsors and contacts
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