The purpose of this study is to evaluate the safety and efficacy of vernakalant injection in subjects with recent onset (AF \> 3 hours to \<= 7 days), symptomatic atrial fibrillation and no evidence or history of congestive heart failure.
Participants received a 10-minute intravenous (IV) infusion of vernakalant (3 mg/kg) or an equivalent amount of normal saline (placebo), followed by a 15-minute observation period. If the participant was still in atrial fibrillation or atrial flutter, a second 10-minute IV infusion of vernakalant (2 mg/kg) or an equivalent amount of placebo was administered unless the participant experienced any dose-stopping criteria after the start of the first infusion. If a participant converted to sinus rhythm during the first or second infusion, that infusion was completed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
217
Maximum volume of 100 mL as per the dosing schedule, administered intravenously (IV) over 10 minutes
Injection
Number of Participants who Experience Hypotension, Ventricular Arrhythmias and/or Death
Hypotension defined as: systolic blood pressure (SBP) \<90 mmHg and treated with pressors; SBP \<90 mmHg and treated with albumin, dextran or hydroxyethyl starch; or SBP \<90 mmHg and seizures. Ventricular arrhythmias defined as: Sustained ventricular tachycardia with a heart rate of \>120 beats per minute. Sustained tachycardia defined as lasting \>30 seconds; Torsade de Pointes with a duration of \>10 seconds; Ventricular fibrillation of any duration.
Time frame: Occurring within the first two hours after start of study treatment
Number of Participant with Successful Conversion to Sinus rhythm (SR)
Successful conversion defined as return to sinus rhythm for at least 1 minute documented by Holter electrocardiogram (ECG) or by two consecutive 12-lead ECGs recorded \> 1 minute apart within 90 minutes of first exposure to study treatment
Time frame: Occurring within 90 minutes of first exposure to study treatment
Time from First Exposure to Study Treatment to Conversion of AF to SR
Time frame: Occurring within 90 minutes after study treatment
Number of Participants who Report No Symptoms
Participant was considered a success (no symptoms) if they did not have any of the following symptoms at 90 minutes: palpitations, dyspnea, dizziness, chest pain or fatigue
Time frame: Occurring 90 minutes after first exposure to study treatment
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