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

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Treatments: Amiodarone

Criteria

Inclusion Criteria:

1. Age >/=18 years

2. 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.

3. Hemodynamically stable with/without vasopressor support

Exclusion Criteria:

1. LVAD insertion or heart transplantation

2. MAZE procedure

3. Transcatheter aortic valve replacement (TAVR)

4. History of or planned mechanical valve replacement

5. Rheumatic heart disease

6. Congenital cardiac defect (excluding bicuspid aortic valve or patent foramen ovale)

7. History of prior atrial fibrillation or flutter

8. History of ablation for atrial fibrillation

9. Contraindication to amiodarone

• PR >240ms

• Heart block (2nd or 3rd degree)

• QTC >480ms

• Untreated thyroid disorder

• AST or ALT >2x upper limit of normal

• Hepatic cirrhosis

• Interstitial lung disease

10. Received amiodarone within 6 weeks

11. Contraindications to Vernakalant

• Known hypersensitivity to Vernakalant

• Prolonged QT

• Heart block (2nd or 3rd degree)

• Use of anti-arrhythmic medication in the past 4 weeks.

12. Return to OR during CVICU stay or readmission to CIVCU from Cardiac Surgery ward.