Actively Recruiting
Clinical Randomised Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
Led by Acesion Pharma · Updated on 2025-12-05
200
Participants Needed
38
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
CONDITIONS
Official Title
Clinical Randomised Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent.
- Age 18 or older.
- ECG documented diagnosis of paroxysmal or persistent AF.
- AF history at screening indicating an expected AF burden of 1-90%, with at least 1 self-terminating AF episode within 4 months prior to screening.
- AF burden of 261% and 2490% assessed with an ECG patch device during screening prior to randomisation.
- Agreement to avoid non-trial rhythm control treatments during the study, including antiarrhythmic drugs (class I or III), cardioversion, or AF ablation.
- Willingness to have a loop recorder implanted.
You will not qualify if you...
- Prior AF ablation procedure other than pulmonary vein isolation only.
- Myocardial infarction, unstable angina, stroke, transient ischemic attack, PCI, CABG, or peripheral revascularisation within 4 weeks before screening.
- Presence of cardiac pacing device with atrial or ventricular pacing >5% of the time or existing implantable loop recorder.
- Heart failure NYHA class III or IV.
- Left ventricular ejection fraction below 40% based on recent imaging.
- Significant valvular heart disease, including severe aortic stenosis, severe mitral regurgitation, or severe mitral stenosis.
- QTc interval >450 ms for males or >470 ms for females at screening.
- Estimated glomerular filtration rate below 60 mL/min/1.73 m2.
- Use of antiarrhythmic drugs (class I or III) within 7 days or amiodarone within 3 months before screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 38 locations
1
UMHAT "Sveti Georgi" EAD, Department of Invasive Cardiology
Plovdiv, PD, Bulgaria, 4002
Not Yet Recruiting
2
Acibadem City Clinic, Cardiology Department
Sofia, SOF, Bulgaria, 1000
Actively Recruiting
3
MHAT National Cardiology Hospital EAD, Cardiology Department
Sofia, SOF, Bulgaria, 1365
Withdrawn
4
Aleksandrovska University Hospital, Clinic of Cardiology
Sofia, SOF, Bulgaria, 1431
Not Yet Recruiting
5
SHATC Cardiolife, Invasive Cardiology
Varna, VAR, Bulgaria, 9000
Actively Recruiting
6
Medical Center Nova Clinic
Varna, VAR, Bulgaria, 9020
Actively Recruiting
7
University Hospital Herlev and Gentofte Department of Cardiology
Hellerup, Denmark, 2730
Actively Recruiting
8
Viborg Hospital, Department of Cardiology
Viborg, Denmark, 8800
Actively Recruiting
9
Sana Kliniken Oberfranken, Klinikum Coburg Kardiologie und Innere Medizin
Coburg, Germany, 96450
Not Yet Recruiting
10
Universitätsklinikum Frankfurt Medizinische Klinik III - Kardiologie, Angiologie, Hämostaseologie, Nephrologie
Frankfurt, Germany, 60590
Actively Recruiting
11
Universitaets Klinikum Hamburg-Eppendorf (UKE Hamburg), Kardiologie
Hamburg, Germany, 20246
Actively Recruiting
12
Budai Irgalmasrendi Kórház
Budapest, Hungary, 1023
Not Yet Recruiting
13
Semmelweis Egyetem Városmajori Sziv- és Érsebészeti Klinika
Budapest, Hungary, 1122
Actively Recruiting
14
Soproni Gyógyközpont Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet
Sopron, Hungary, 9400
Not Yet Recruiting
15
Szent-Györgyi Albert Klinikai Központ, Belgyógyászati Klinika
Szeged, Hungary, 6725
Not Yet Recruiting
16
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Rendelőintézet
Szolnok, Hungary, 5000
Not Yet Recruiting
17
Belvárosi Egészségház, Platán Magánklinika
Zalaegerszeg, Hungary, 8900
Not Yet Recruiting
18
Policlinico Sant'Orsola Cardiology Department
Bologna, BO, Italy, 40138
Not Yet Recruiting
19
Arcispedale Sant'Anna, Cardiology Department
Cona, FE, Italy, 444124
Not Yet Recruiting
20
ASST Grande Ospedale Metropolitano Niguarda Cardiology 3 - Electrophysiology "De Gasperis" Cardio Center
Milan, Michigan, Italy, 20162
Not Yet Recruiting
21
University of Modena and Reggio Emilia, Policlinico di Modena, Cardiology Department
Modena, Missouri, Italy, 30174
Not Yet Recruiting
22
Dell'Angelo Hospital, Cardiology Department
Mestre, VE, Italy, 30174
Not Yet Recruiting
23
Rijnstate Ziekenhuis, Cardiology Department
Arnhem, Netherlands, 6815 AD
Actively Recruiting
24
Deventer Ziekenhuis, Cardiology Department
Deventer, Netherlands, 7416 SE
Actively Recruiting
25
Martini Hospital Groningen, Cardiology Department
Groningen, Netherlands, 9728 NT
Actively Recruiting
26
Spaarne Gasthuis, Cardiology Department
Haarlem, Netherlands, 2035 RC
Actively Recruiting
27
Frisius MC Leeuwarden, Hart- en Vaatcentrum
Leeuwarden, Netherlands, 8934 AD
Actively Recruiting
28
Maastricht University Medical Center, Cardiology Department
Maastricht, Netherlands, 6229 HX
Not Yet Recruiting
29
HagaZiekenhuis, Cardiology/Electrophysiology Unit
The Hague, Netherlands, 2545 AA
Not Yet Recruiting
30
Rivierenland Hospital, Cardiology Department
Tiel, Netherlands, 4002 WP
Actively Recruiting
31
Máxima Medisch Centrum, Cardiology Department
Veldhoven, Netherlands, 5504 DB
Actively Recruiting
32
Centrum Medyczne KERmed Cardiology Department
Bydgoszcz, Poland, 85-231
Not Yet Recruiting
33
Małopolskie Centrum Sercowo-Naczyniowe PAKS Oddział Intensywnej Opieki Kardiologicznej
Chrzanów, Poland, 85-231
Not Yet Recruiting
34
Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
Dąbrowa Górnicza, Poland, 41-300
Actively Recruiting
35
Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland, 40-635
Not Yet Recruiting
36
Upper-Silesian Medical Center 2nd Department of Cardiology
Katowice, Poland, 40-635
Not Yet Recruiting
37
One Day Med Sp. z o.o. Clinical Trials Department
Szczecin, Poland, 70-419
Not Yet Recruiting
38
Polsko-Amerykańskie Kliniki Serca X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach im
Tychy, Poland, 43-100
Actively Recruiting
Research Team
B
Birgitte Vestbjerg
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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