Phase
Condition
Dysrhythmia
Circulation Disorders
Atrial Fibrillation
Treatment
PKN605
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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 anyother 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, ECGpatch monitor, or other ambulatory electrocardiographic monitor within the last 12months
CHA2DS2-VASc score of 2 or higher in males, 3 or higher in females (1 point forcongestive heart failure, hypertension, age 65-74 years, diabetes, vascular disease,female sex; 2 points for age 75 years or older, prior stroke or transient ischemicattack)
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 theInvestigator
Participants must have a body mass index (BMI) ≥ 18 kg/m2. BMI is calculated asbody weight (kg) divided by height (m) squared
Inclusions at Day 1
Sinus rhythm at Baseline documented by 12-lead ECG (participants withpersistent AF should be cardioverted at least 12 hours before randomization)
Exclusion
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 IIIanti-arrhythmic therapy must be discontinued at least 7 days before Screening phaseECG patch monitor; amiodarone must be discontinued at least 6 weeks before Screeningphase ECG patch monitor)
History of an AF ablation procedure within the last 6 months without a recurrence ofAF 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 12months, or during Screening
Current decompensated heart failure or hospitalization for heart failure within 3months prior to Screening
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
London 6058560, Ontario 6093943 N6A 5W9
CanadaActive - Recruiting
Novartis Investigative Site
Newmarket 6087701, Ontario 6093943 L3Y 2P6
CanadaActive - Recruiting
Novartis Investigative Site
Toronto 6167865, Ontario 6093943 M5B 1W8
CanadaActive - Recruiting
Novartis Investigative Site
Montreal 6077243, Quebec 6115047 H1T 1C8
CanadaActive - Recruiting
Novartis Investigative Site
Québec 6325494, Quebec 6115047 G1V 4G5
CanadaActive - Recruiting
Novartis Investigative Site
Sherbrooke 6146143, Quebec 6115047 J1H 5N4
CanadaActive - Recruiting
Novartis Investigative Site
Beijing 1816670, Beijing Municipality 2038349 100013
ChinaActive - Recruiting
Novartis Investigative Site
Xi'an 1790630, 223001
ChinaActive - Recruiting
Novartis Investigative Site
Bad Homburg 2953436, 61348
GermanyActive - Recruiting
Novartis Investigative Site
Berlin 2950159, 10787
GermanyActive - Recruiting
Novartis Investigative Site
Hamburg 2911298, 20246
GermanyActive - Recruiting
Novartis Investigative Site
Delft 2757345, South Holland 2743698 2625 AD
NetherlandsActive - Recruiting
Novartis Investigative Site
Goes 2755476, Zeeland 2744011 4462 RA
NetherlandsActive - Recruiting
Novartis Investigative Site
Veldhoven 2745706, 5504 DB
NetherlandsActive - Recruiting
Novartis Investigative Site
Singapore 1880252, 119074
SingaporeActive - Recruiting
Novartis Investigative Site
Brighton 2654710, East Sussex BN2 5BE
United KingdomActive - Recruiting
Novartis Investigative Site
London 2643743, W12 0HS
United KingdomActive - Recruiting
Cardiology Associates of North MS
Tupelo 4448903, Mississippi 4436296 38801
United StatesActive - Recruiting
Weill Cornell Medical Center
New York 5128581, New York 5128638 10021
United StatesActive - Recruiting
Intermountain Medical Center
Murray 5778755, Utah 5549030 84107
United StatesActive - Recruiting
Swedish Heart and Vascular Clinic
Seattle 5809844, Washington 5815135 98122
United StatesActive - Recruiting

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