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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Vernakalant | Experimental | Patients randomized to Vernakalant will receive a bolus of 3mg/kg over 10 minutes and an observation period of 15 minutes, if the patient is still in AF, they will receive an additional 2.0mg/kg bolus of Vernakalant. |
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| Intravenous Amiodarone | Active Comparator | Patients randomized to an amiodarone arm will receive 150mg IV bolus and an amiodarone infusion of 1mg/hr x 6 hours followed by 0.5mg/hr x 12 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of conversion of sustained post-operative atrial fibrillation at 90 minutes. | Rate of conversion of sustained post-operative atrial fibrillation at 90 minutes. | 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of vasopressor therapy | Duration of vasopressor therapy | 7 days |
| Time to conversion to sinus rhythm | Time to conversion to sinus rhythm |
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Inclusion Criteria:
Exclusion Criteria:
LVAD insertion or heart transplantation
MAZE procedure
Transcatheter aortic valve replacement (TAVR)
History of or planned mechanical valve replacement
Rheumatic heart disease
Congenital cardiac defect (excluding bicuspid aortic valve or patent foramen ovale)
History of prior atrial fibrillation or flutter
History of ablation for atrial fibrillation
Contraindication to amiodarone
Received amiodarone within 6 weeks
Contraindications to Vernakalant
Return to OR during CVICU stay or readmission to CIVCU from Cardiac Surgery ward.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Chiu, MD, MSC | Contact | 4032106818 | michael.chiu@albertahealthservices.ca | |
| Vikas Kuriachan, MD | Contact | 4032106818 | vpkuriac@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michael Chiu, MD, MSC | University of Calgary | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18332267 | Background | Roy D, Pratt CM, Torp-Pedersen C, Wyse DG, Toft E, Juul-Moller S, Nielsen T, Rasmussen SL, Stiell IG, Coutu B, Ip JH, Pritchett EL, Camm AJ; Atrial Arrhythmia Conversion Trial Investigators. Vernakalant hydrochloride for rapid conversion of atrial fibrillation: a phase 3, randomized, placebo-controlled trial. Circulation. 2008 Mar 25;117(12):1518-25. doi: 10.1161/CIRCULATIONAHA.107.723866. Epub 2008 Mar 10. | |
| 19948506 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Product monograph - Vernakalant | View IPD |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C524581 | vernakalant |
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Patients will be recruited from the CVICU 24 hours after admission to CIVCU based on inclusion and exclusion criteria. Patients identified with new presentation atrial fibrillation with a sustained duration of greater than 30 minutes will be considered for the study. Patients will be randomized to Amiodarone versus Vernakalant using a computerized process.
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|
| 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 |
|
|
| 7 days |
| Days in intensive care unit | Days in intensive care unit | 7 Days |
| Recurrence of atrial fibrillation within 48 hours | Recurrence of atrial fibrillation within 48 hours | 48 hours |
| Mortality | Mortality | 1 month |
| LV function (Normal, Mild, Moderate or Severe) | LV function (Normal, Mild, Moderate or Severe) | 7 days |
| Time to initiation of beta-blockers | Time to initiation of beta-blockers | 7 days |
| Economics - cost of hospital stay | Economics - cost of hospital stay | Up to one month |
| Background |
| Kowey PR, Dorian P, Mitchell LB, Pratt CM, Roy D, Schwartz PJ, Sadowski J, Sobczyk D, Bochenek A, Toft E; Atrial Arrhythmia Conversion Trial Investigators. Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009 Dec;2(6):652-9. doi: 10.1161/CIRCEP.109.870204. |
| 21232669 | Background | Camm AJ, Capucci A, Hohnloser SH, Torp-Pedersen C, Van Gelder IC, Mangal B, Beatch G; AVRO Investigators. A randomized active-controlled study comparing the efficacy and safety of vernakalant to amiodarone in recent-onset atrial fibrillation. J Am Coll Cardiol. 2011 Jan 18;57(3):313-21. doi: 10.1016/j.jacc.2010.07.046. |
| Product monograph - Amiodarone | View IPD |
| D013568 |
| Pathological Conditions, Signs and Symptoms |