NCT04748991Not yet recruitingPhase 3
Vernakalant Versus Amiodarone for Post-operative Atrial Fibrillation in Cardiac Surgery Patients
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 25 Jan 2021
- Start date
- Sept 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- University of Calgary
- Diseases
- Atrial fibrillation
- NCT number
- NCT04748991
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 50
- From Sept 2026 to the primary completion date, Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior atrial fibrillation or flutter
- Received amiodarone within 6 weeks
Other illness
- LVAD insertion or heart transplantation
- History of or planned mechanical valve replacement
- Rheumatic heart disease
- Congenital cardiac defect (excluding bicuspid aortic valve or patent foramen ovale)
- History of ablation for atrial fibrillation
- Return to OR during CVICU stay or readmission to CIVCU from Cardiac Surgery ward.
Lab values
- 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
- 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.
Other
- MAZE procedure
- Transcatheter aortic valve replacement (TAVR)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.