Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study of the Effects of K201 Injection, 2 mg/mL on the Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation

To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.

Inclusion Criteria:

• Symptomatic atrial fibrillation
• Atrial fibrillation documented by ECG
• Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment.

Exclusion Criteria:

• Systolic blood pressure <100 mmHg
• Heart rate <50 bpm
• Temperature >38°C
• QT or QTcB >440 ms
• QRS >140 ms
• Paced atrial or ventricular rhythm on ECG
• Serum potassium <3.5 meq/L
• History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
• History of amiodarone in last 6 months.
• Clinical evidence of acute coronary syndrome
• Acute pulmonary edema or embolism
• Hyperthyroidism
• Acute pericarditis
• History of failed electrical cardioversion at any time
• History of torsades des pointes
• History of familial long QT interval syndrome
• History of ventricular tachycardia requiring drug or device therapy
• History of NYHA Heart Failure Class 3 or 4.