Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm

Inclusion Criteria

• provide written informed consent,
• male or female 18 years of age or greater; women of child bearing potential must use adequate contraception
• symptomatic AF/AFL for more than 3 hours and less than 7 days (168 hours), as dated by symptoms
• AF/AFL documented by ECG at the start of study drug administration

Exclusion Criteria

• Systolic blood pressure 440 ms.
• Average QRS interval >140 ms.
• Paced atrial or ventricular rhythm on ECG.
• Serum potassium <3.5 meq/L (may be corrected prior to randomization).
• Received another intravenous Class I or Class III antiarrhythmic drug within prior 3 days.
• received amiodarone (oral or IV) in prior 3 months.
• Clinical evidence or history of acute coronary syndrome within 30 days prior to randomization.
• Aortic stenosis with aortic valve area equal to or less than 1.0 cm2.
• Rheumatic mitral stenosis with valve area of <1.5 cm2.
• Untreated hyperthyroidism.
• Acute pericarditis.
• AF/AFL as a result of surgery within the last 7 days
• History of failed electrical cardioversion
• History of polymorphic ventricular tachycardia (PVT, e.g. torsades de pointes).
• History or family history of long QT syndrome.
• History of ventricular tachycardia requiring drug or device therapy.
• History of NYHA Heart Failure Class 3 or 4 or recent (within 1 month) onset of heart failure not related to rapid ventricular response AF.
• Ejection fraction (EF) of 35% or less.