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

Inclusion Criteria:

- Subject has been informed of the investigational nature of this study and has given
written informed consent in accordance with institutional, local, and national
guidelines.

- Able to return for Day 8 follow up.

- Male or female 18 years of age or greater.

- Onset of AF/AFL within the 7 calendar days preceding randomization, based on
symptoms.

- AF/AFL documented by ECG during the screening period.

- Adherence to local clinical standards or the ACC/AHA or ESC practice guidelines for
AF/AFL regarding thromboembolic event prevention and treatment.

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.