Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation (TUNDRA-AF)

Sequel Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Atrial Fibrillation

Treatments

Drug: K201

Drug: saline

Study type

Interventional

Funder types

Industry

Identifiers

NCT01259622

CJI-202

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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
Ejection fraction of 40% or less.