Vernakalant Versus Amiodarone for Post-operative Atrial Fibrillation in Cardiac Surgery Patients

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Calgary

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Vernakalant

    Drug

    Post operative AF after cardiac surgery. Vernakalant 3mg/kg over 10 minutes followed by 2mg/kg over 10 minutes if still in AF.

  • Amiodarone

    Drug

    Post 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

50 Participants
are divided into 2 treatment groups
Group A: Intravenous VernakalantExperimental treatment 1 intervention
Group B: Intravenous AmiodaroneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of conversion of sustained post-operative atrial fibrillation at 90 minutes.

Rate of conversion of sustained post-operative atrial fibrillation at 90 minutes.

Time frame
90 minutes

Secondary outcomes

1

Duration of vasopressor therapy

Duration of vasopressor therapy

Time frame
7 days
2

Time to conversion to sinus rhythm

Time to conversion to sinus rhythm

Time frame
7 days
3

Days in intensive care unit

Days in intensive care unit

Time frame
7 Days
4

Recurrence of atrial fibrillation within 48 hours

Recurrence of atrial fibrillation within 48 hours

Time frame
48 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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