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

REB20-2257

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.

2024-09-01

2025-01-01

2025-09-01

Not yet recruiting

Early phase I

50

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2024-05-22