Last Update: Jul 31, 2026 A Randomized, Placebo-controlled, Participant- and Investigator-blinded Study to Evaluate the Efficacy in Reducing Atrial Fibrillation Burden (AFB) as Well as the Safety, Tolerability, and Pharmacokinetics of Oral PKN605 in Participants With Atrial Fibrillation ClinicalTrials.gov Identifier: [NCT07217067](https://clinicaltrials.gov/ct2/show/NCT07217067) Novartis Reference Number:CPKN605A12201 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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 A screening period of up to 90 days will be conducted to determine participants' eligibility. Once eligibility is confirmed, participants will be randomly assigned to receive either PKN605 or placebo. The treatment phase will last for 24 weeks, during which participants will visit the clinic approximately once a month. During the study, participants' atrial fibrillation will be monitored using various ECG devices. Approximately one month after the end of the treatment phase, participants will have a final safety follow-up visit. The primary purpose of the study is to monitor the effect PKN605 has on the amount of time participants spend in atrial fibrillation. Condition Atrial Fibrillation Phase Phase2 Overall Status Recruiting Number of Participants165 Start Date Oct 28, 2025 Completion Date Sep 09, 2027 Gender All Age(s) 18 Years - (Adult, Older Adult) ## Interventions Drug ### PKN605 PKN605 is an oral formulation Other ### Placebo Matching placebo ## Eligibility Criteria Inclusion Criteria: \* 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) \* 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 \* Participants must have a body mass index (BMI) ≥ 18 kg/m2. BMI is calculated as body weight (kg) divided by height (m) squared \* Inclusions at Day 1 \* Sinus rhythm at Baseline documented by 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization) Exclusion Criteria: -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 \* Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening Canada #### Novartis Investigative Site Recruiting London,Ontario,N6a 5w9,Canada #### Novartis Investigative Site Recruiting Halifax,Nova Scotia,B3h 3a7,Canada #### Novartis Investigative Site Recruiting Toronto,Ontario,M4n 3m5,Canada #### Novartis Investigative Site Recruiting Hamilton,Ontario,L8l 2x2,Canada #### Novartis Investigative Site Recruiting Vancouver,British Columbia,V5z 1m9,Canada #### Novartis Investigative Site Recruiting Calgary,Alberta,T2p 3c5,Canada #### Novartis Investigative Site Recruiting Montreal,Quebec,H4a 3j1,Canada #### Novartis Investigative Site Recruiting Toronto,Ontario,M5b 1w8,Canada #### Novartis Investigative Site Recruiting Newmarket,Ontario,L3y 2p6,Canada #### Novartis Investigative Site Recruiting Montreal,Quebec,H1t 1c8,Canada #### Novartis Investigative Site Recruiting Sherbrooke,Quebec,J1h 5n4,Canada #### Novartis Investigative Site Recruiting Montreal,Quebec,H2x 1r9,Canada #### Novartis Investigative Site Recruiting Québec,Quebec,G1v 4g5,Canada China #### Novartis Investigative Site Recruiting Beijing,100730,China #### Novartis Investigative Site Recruiting Beijing,Beijing Municipality,100013,China #### Novartis Investigative Site Recruiting Xi'an,223001,China Germany #### Novartis Investigative Site Recruiting Hamburg,20246,Germany #### Novartis Investigative Site Recruiting Berlin,13353,Germany #### Novartis Investigative Site Recruiting Berlin,10787,Germany #### Novartis Investigative Site Recruiting Hamburg,20099,Germany #### Novartis Investigative Site Recruiting Bad Homburg,61348,Germany Netherlands #### Novartis Investigative Site Recruiting Delft,South Holland,2625 ad,Netherlands #### Novartis Investigative Site Recruiting Veldhoven,5504 db,Netherlands #### Novartis Investigative Site Recruiting Groningen,9713 gz,Netherlands #### Novartis Investigative Site Recruiting Goes,Zeeland,4462 ra,Netherlands #### Novartis Investigative Site Recruiting Arnhem,Gelderland,6815 ad,Netherlands #### Novartis Investigative Site Recruiting Maastricht,Limburg,6229 hx,Netherlands Singapore #### Novartis Investigative Site Recruiting Singapore,169609,Singapore #### Novartis Investigative Site Recruiting Singapore,Singapore,S308433,Singapore #### Novartis Investigative Site Recruiting Singapore,119074,Singapore United Kingdom #### Novartis Investigative Site Recruiting Brighton,East Sussex,Bn2 5be,United Kingdom #### Novartis Investigative Site Recruiting Newcastle upon Tyne,Tyne and Wear,Ne7 7dn,United Kingdom #### Novartis Investigative Site Recruiting London,W12 0hs,United Kingdom United States #### Cardiology Associates of North MS Recruiting Tupelo,Mississippi,38801,United States ###### James Edgar Stone ###### Brittany Cook Email: #### Duke Univ Medical Center Recruiting Durham,North Carolina,27710,United States ###### Jessalyn Davis Email: ###### Jonathan Piccini #### Swedish Heart and Vascular Clinic Recruiting Seattle,Washington,98122,United States ###### Serena Risher Phone: [+1 206 386 6462]() Email: ###### David Lam #### Intermountain Medical Center Recruiting Murray,Utah,84107,United States ###### Paden Hansen Email: ###### Michael Cutler #### Weill Cornell Medical Center Recruiting New York,New York,10021,United States ###### Jim Way Cheung ###### Penn Collins Email: #### Cooper University Hospital Recruiting Camden,New Jersey,08103,United States ###### Andrea Russo ###### Ifeoluwa Onuoha Phone: [+1 856 342 2000]() Email: ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: [](mailto:) #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: