Actively Recruiting
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
Eligibility Criteria
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
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
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
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14
Novartis Investigative Site
Montreal, Quebec, Canada, H2X 1R9
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15
Novartis Investigative Site
Montreal, Quebec, Canada, H4A 3J1
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16
Novartis Investigative Site
Québec, Quebec, Canada, G1V 4G5
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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
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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
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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