Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07217067

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

Led by Novartis Pharmaceuticals · Updated on 2026-04-17

165

Participants Needed

38

Research Sites

97 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent obtained before participation
  • Male or female aged 18 years or older
  • History of at least 2 episodes of atrial fibrillation or atrial flutter, including at least one atrial fibrillation episode
  • At least one atrial fibrillation episode documented within the last 12 months by ECG or equivalent
  • One or more of the following: atrial fibrillation burden of 1% or higher on an ambulatory ECG monitor within 12 months, CHA2DS2-VASc score ≥2 in males or ≥3 in females, stable heart failure with NYHA class I or II symptoms, or NT-proBNP level ≥300 pg/mL within 12 months
  • On guideline-directed stroke prevention treatment confirmed by the investigator
  • Body mass index (BMI) of 18 kg/m2 or higher
  • Sinus rhythm at baseline documented by 12-lead ECG; participants with persistent atrial fibrillation should be cardioverted at least 12 hours before randomization
Not Eligible

You will not qualify if you...

  • Permanent atrial fibrillation
  • Ongoing reversible causes of atrial fibrillation such as hyperthyroidism, myocarditis, acute alcohol use, infection-related AF, surgery-related AF, or pulmonary embolism
  • Current use of Vaughan Williams class I or III antiarrhythmic therapy within 7 days prior to screening or amiodarone within 6 weeks prior to screening
  • History of atrial fibrillation ablation without recurrence at least 2 months after procedure
  • Implanted pacemaker, defibrillator, or cardiac monitor
  • Infiltrative or hypertrophic cardiomyopathy
  • Left ventricular ejection fraction of 40% or less within last 12 months or during screening
  • Current decompensated heart failure or hospitalization for heart failure within 3 months prior to screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 38 locations

1

Cardiology Associates of North MS

Tupelo, Mississippi, United States, 38801

Actively Recruiting

2

Weill Cornell Medical Center

New York, New York, United States, 10021

Actively Recruiting

3

Duke Univ Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

4

Intermountain Medical Center

Murray, Utah, United States, 84107

Actively Recruiting

5

Swedish Heart and Vascular Clinic

Seattle, Washington, United States, 98122

Actively Recruiting

6

Novartis Investigative Site

Calgary, Alberta, Canada, T2P 3C5

Actively Recruiting

7

Novartis Investigative Site

Vancouver, British Columbia, Canada, V5Z 1M9

Actively Recruiting

8

Novartis Investigative Site

Hamilton, Ontario, Canada, L8L 2X2

Actively Recruiting

9

Novartis Investigative Site

London, Ontario, Canada, N6A 5W9

Actively Recruiting

10

Novartis Investigative Site

Newmarket, Ontario, Canada, L3Y 2P6

Actively Recruiting

11

Novartis Investigative Site

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

12

Novartis Investigative Site

Toronto, Ontario, Canada, M5B 1W8

Actively Recruiting

13

Novartis Investigative Site

Montreal, Quebec, Canada, H1T 1C8

Actively Recruiting

14

Novartis Investigative Site

Montreal, Quebec, Canada, H2X 1R9

Actively Recruiting

15

Novartis Investigative Site

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

16

Novartis Investigative Site

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

17

Novartis Investigative Site

Sherbrooke, Quebec, Canada, J1H 5N4

Actively Recruiting

18

Novartis Investigative Site

Beijing, Beijing Municipality, China, 100013

Actively Recruiting

19

Novartis Investigative Site

Beijing, China, 100730

Actively Recruiting

20

Novartis Investigative Site

Xi'an, China, 223001

Actively Recruiting

21

Novartis Investigative Site

Bad Homburg, Germany, 61348

Actively Recruiting

22

Novartis Investigative Site

Berlin, Germany, 10787

Actively Recruiting

23

Novartis Investigative Site

Berlin, Germany, 13353

Actively Recruiting

24

Novartis Investigative Site

Hamburg, Germany, 20099

Actively Recruiting

25

Novartis Investigative Site

Hamburg, Germany, 20246

Actively Recruiting

26

Novartis Investigative Site

Arnhem, Gelderland, Netherlands, 6815 AD

Actively Recruiting

27

Novartis Investigative Site

Maastricht, Limburg, Netherlands, 6229 HX

Actively Recruiting

28

Novartis Investigative Site

Delft, South Holland, Netherlands, 2625 AD

Actively Recruiting

29

Novartis Investigative Site

Goes, Zeeland, Netherlands, 4462 RA

Actively Recruiting

30

Novartis Investigative Site

Groningen, Netherlands, 9713 GZ

Actively Recruiting

31

Novartis Investigative Site

Veldhoven, Netherlands, 5504 DB

Actively Recruiting

32

Novartis Investigative Site

Singapore, Singapore, Singapore, S308433

Actively Recruiting

33

Novartis Investigative Site

Singapore, Singapore, 119074

Actively Recruiting

34

Novartis Investigative Site

Singapore, Singapore, 169609

Actively Recruiting

35

Novartis Investigative Site

Brighton, East Sussex, United Kingdom, BN2 5BE

Actively Recruiting

36

Novartis Investigative Site

Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN

Actively Recruiting

37

Novartis Investigative Site

Liverpool, United Kingdom, L14 3PE

Actively Recruiting

38

Novartis Investigative Site

London, United Kingdom, W12 0HS

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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