Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01259622

Acronym

TUNDRA-AF

Enrollment

Registered

2010-12-14

Start date

2011-02-28

Completion date

2011-12-31

Last updated

2011-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

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.

Interventions

DRUGsaline

intravenous infusion

DRUGK201

intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
proportion of subjects who convert to sinus rhythm	24 hours

Countries

Denmark, Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026