Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm

Exclusion Criteria

• •Previous exposure to vanoxerine HCl.
• •Women of childbearing potential (neither surgically sterilized nor post-menopausal defined as cessation of menses for over one year)
• •Systolic blood pressure \<110 mmHg (unless documented to be usual value).
• •Average heart rate \<60 bpm documented by screening ECG.
• •Average QTc \>440 msec documented by screening ECG.
• •QRS interval \>140 msec documented by screening ECG.
• •Paced atrial rhythm on screening ECG.
• •History of receiving another Class I or Class III antiarrhythmic drug within 3 days prior to randomization. Excluded Class I antiarrhythmic drugs include quinidine, procainamide, disopyramide, lignocaine, mexilitine, flecainide, and propafenone. Excluded Class III drugs include dofetilide, sotalol, dronedarone, and ranolazine.
• •History of amiodarone (oral or IV) within the 90 days prior to randomization.
• •Native or prosthetic aortic or mitral stenosis with aortic valve area ≤1.0 cm2 or mitral valve area of \<1.5 cm2 or any other valvular diseases for which surgery is indicated.
• •Treatment with any loop diuretic (e.g., furosemide, bumetanide, torsemide, ethacrynic acid, etc.) in the 30 days prior to randomization.
• •Ejection fraction of \<35% within the 3 months prior to randomization (most recent measure if more than one).
• •AF/AFL as a result of surgery (postoperative AF/AFL) within 30 days prior to randomization.
• •History of electrical cardioversion within the 7 calendar days prior to randomization.
• •History of any polymorphic ventricular tachycardia including torsades de pointes.
• •History or family history of long QT syndrome or other inherited arrhythmia syndrome.
• •History of ventricular tachycardia requiring drug or device therapy.