About this trial
A randomized, placebo-controlled, participant-and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation
Eligibility criteria
Qualifiers
Inclusions at Screening
Signed informed consent must be obtained prior to participation in the study
Male and female participants ≥ 18 years of age
History of at least 2 episodes of AF (atrial fibrillation or atrial flutter), at least one episode must be atrial fibrillation
Disqualifiers
Permanent AF
Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, sepsis- or infection related AF, surgery-related AF, pulmonary embolism)
Ongoing use of antiarrhythmic therapy (Vaughan Williams class I or III anti-arrhythmic therapy must be discontinued at least 7 days before Screening phase ECG patch monitor; amiodarone must be discontinued at least 6 weeks before Screening phase ECG patch monitor)
History of an AF ablation procedure without a recurrence of AF at least 2 or more months after the ablation.
Trial design
Treatments tested in this trial
- PKN605
- Placebo