Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation (TUNDRA-AF)
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The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A mulTi-center, Randomized, doUble-bliNded, Placebo-controlled Dose-escalating Study of the Effects of K201 on the RestorAtion of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation of Recent Onset
Study Start Date
Estimated Primary Completion Date
Estimated Study Completion Date
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms).
Atrial fibrillation documented by ECG at the start of study drug infusion.
Previous exposure to K201
QTcF (Fridericia correction) >440 ms
QRS interval > 140 ms
Paced atrial or paced ventricular rhythm on ECG
History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
History of amiodarone (oral or IV) in the last 3 months.
Clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization
History of failed electrical cardioversion at any time in the past
History of polymorphic ventricular tachycardia (e.g. torsades des pointes)
History or family history of Long QT Syndrome
History of ventricular tachycardia requiring drug or device therapy