RecruitingAtrial Fibrillation
A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
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
Sponsor: Novartis Pharmaceuticals
You may qualify if…
- ✓ 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
- ✓ At least 1 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:
- ✓ 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 years, diabetes, vascular disease, female sex; 2 points for age 75 years or older, prior stroke or transient ischemic attack)
You may not qualify if…
- ✕ Exclusions at Screening
- ✕ 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.
- ✕ Implanted pacemaker, defibrillator, or cardiac monitor
- ✕ Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy
- ✕ Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during Screening. If multiple LVEF measurements are recorded within the last 12 months, the most recent LVEF measurement should be used
Where it's recruiting
Source: ClinicalTrials.gov · NCT07217067 · last updated 2026-07-31