Tests PKN605 tablets for atrial fibrillation, an irregular heartbeat

Who can take part

• 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 fibrilation
• At least one of the AF episodes specified in Inclusion #3 must be within the last 12 months (or during Screening) and documented by 12-lead, ECG, Holter, or any other ECG recording method, as confirmed by the Investigator
• One or more of the following, at Screening: • AFB of 1% or higher on a local ambulatory Holter, mobile cardiac telemetry, ECG patch monitor, or other ambulatory electrocardiographic monitor within the last 12 months • CHA2DS2-VASc score of 2 or higher in males, 3 or higher in females (1 point for congestive heart failure, hypertension, age 65-74, diabetes, vascular disease, female sex; 2 points for age 75 years or older, prior stroke or transient ischemic attack) • Stable heart failure or with New York Heart Association class I or II symptoms • NT-proBNP level of 300 pg/mL or higher on a local lab test within the last 12 months
• On guideline-directed stroke prevention treatment, as confirmed by the investigator, at Screening
• Participants must have a body mass index (BMI) >18 kg/m2. BMI is calculated as body weight (kg) divided by height in (m) squared
• Sinus rhythm at Baseline as documented by a 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization)

Who cannot take part

• Ongoing use of antiarrhythmic therapy (Vaughan Williams class l 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)
• Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening
• Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, alcohol use, sepsis- or infection-related AF, surgery-related AF, pulmonary embolism)
• History of an AF ablation procedure without a recurrence of AF at least 2 or more months after the ablation
• Implanted pacemaker, defibrillator, or cardiac monitor
• Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during the Screening period. If multiple LVEF measurements are recorded within last 12 months, the most recent LVEF measurement should be used
• Permanent AF
• Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy