NCT07217067From ClinicalTrials.govRecruiting

A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation

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

Atrial Fibrillation

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Novartis Pharmaceuticals
Enrolment target: 165
Started: 28 October 2025
Main results due: 9 September 2027
Study sites: 40
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(40)

Cardiology Associates of North MS
Tupelo, Mississippi, United States
Recruiting
Cooper University Hospital
Camden, New Jersey, United States
Recruiting
Weill Cornell Medical Center
New York, New York, United States
Recruiting
Duke Univ Medical Center
Durham, North Carolina, United States
Recruiting
Intermountain Medical Center
Murray, Utah, United States
Recruiting
Swedish Heart and Vascular Clinic
Seattle, Washington, United States
Recruiting
Novartis Investigative Site
Calgary, Alberta, Canada
Recruiting
Novartis Investigative Site
Vancouver, British Columbia, Canada
Recruiting
Novartis Investigative Site
Halifax, Nova Scotia, Canada
Recruiting
Novartis Investigative Site
Hamilton, Ontario, Canada
Recruiting
Novartis Investigative Site
London, Ontario, Canada
Recruiting
Novartis Investigative Site
Newmarket, Ontario, Canada
Recruiting
Novartis Investigative Site
Toronto, Ontario, Canada
Recruiting
Novartis Investigative Site
Toronto, Ontario, Canada
Recruiting
Novartis Investigative Site
Montreal, Quebec, Canada
Recruiting
Novartis Investigative Site
Montreal, Quebec, Canada
Recruiting
Novartis Investigative Site
Montreal, Quebec, Canada
Recruiting
Novartis Investigative Site
Québec, Quebec, Canada
Recruiting
Novartis Investigative Site
Sherbrooke, Quebec, Canada
Recruiting
Novartis Investigative Site
Beijing, Beijing Municipality, China
Recruiting
Novartis Investigative Site
Beijing, China
Recruiting
Novartis Investigative Site
Xi'an, China
Recruiting
Novartis Investigative Site
Bad Homburg, Germany
Recruiting
Novartis Investigative Site
Berlin, Germany
Recruiting
Novartis Investigative Site
Berlin, Germany
Recruiting
Novartis Investigative Site
Hamburg, Germany
Recruiting
Novartis Investigative Site
Hamburg, Germany
Recruiting
Novartis Investigative Site
Arnhem, Gelderland, Netherlands
Recruiting
Novartis Investigative Site
Maastricht, Limburg, Netherlands
Recruiting
Novartis Investigative Site
Delft, South Holland, Netherlands
Withdrawn
Novartis Investigative Site
Goes, Zeeland, Netherlands
Recruiting
Novartis Investigative Site
Groningen, Netherlands
Recruiting
Novartis Investigative Site
Veldhoven, Netherlands
Recruiting
Novartis Investigative Site
Singapore, Singapore, Singapore
Recruiting
Novartis Investigative Site
Singapore, Singapore
Recruiting
Novartis Investigative Site
Singapore, Singapore
Recruiting
Novartis Investigative Site
Brighton, East Sussex, United Kingdom
Recruiting
Novartis Investigative Site
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Recruiting
Novartis Investigative Site
Liverpool, United Kingdom
Withdrawn
Novartis Investigative Site
London, United Kingdom
Recruiting

Showing 40 of 40 sites. 38 of the 40 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07217067. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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