Status:
NOT_YET_RECRUITING
Vernakalant Versus Amiodarone for Post-operative Atrial Fibrillation in Cardiac Surgery Patients
Lead Sponsor:
University of Calgary
Conditions:
Atrial Fibrillation
Post-cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 hypotensi...
Detailed Description
1. Background - Atrial fibrillation (AF) is the most common cardiac arrhythmia post cardiac surgery. Estimates suggest that rates of patients experiencing post-operative atrial fibrillation (POAF) aft...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
- Received amiodarone within 6 weeks
- 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.
- Return to OR during CVICU stay or readmission to CIVCU from Cardiac Surgery ward.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04748991
Start Date
September 1 2024
End Date
September 1 2025
Last Update
May 22 2024
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