Clinical Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Atrial Fibrillation (AF)

In brief

A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.

Key facts

Study ID: NCT07267949
Run by: Acesion Pharma
People needed: 200
Starts: 2025-10-22
Expected to finish: 2026-12-01
Last updated by the study team: 2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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%, i.e., at least 1 self-terminating AF episode within 4 months prior to the screening visit.
AF burden of ≥ 1% and ≤ 90% assessed with an ECG patch device during the screening period prior to the randomisation visit.
Investigator and participant agreement to avoid non-trial related rhythm control intervention for the duration of the trial, including:
Antiarrhythmic drug class I and/or III (including amiodarone)
Electrical or pharmacological cardioversion
AF ablation procedure
Willing to have a loop recorder implanted.

You may not qualify if…

Prior AF ablation procedure other than pulmonary vein isolation (PVI) only.
Any of the following events within 4 weeks prior to the screening visit: Myocardial infarction, Unstable angina pectoris, Stroke or transient, ischaemic attack, Percutaneous coronary intervention (PCI), Coronary artery bypass graft (CABG), Peripheral revascularisation procedure.
Cardiac pacing device e.g. pacemaker and cardiac resynchronization therapy device with atrial or ventricular pacing for > 5% of the time or existing implantable loop recorder.
Heart failure, New York Heart Association class III (3) or IV (4).
Left ventricular ejection fraction < 40% based on imaging (e.g. echocardiography) performed within 6 months prior to or during the screening visit.
Clinically significant valvular heart disease, including severe aortic stenosis, severe mitral regurgitation and/or severe mitral stenosis, in the opinion of the investigator.
QTc (Fridericia, QTcF) interval > 450 ms for males and > 470 ms for females at screening.
eGFR <60 mL/min /1.73 m² based on creatine and CKD-EPI formula
Use of antiarrhythmic drug class I and/or III within 7 days or, for amiodarone, within 3 months prior to the screening visit.

Where it is running

Universitaets Klinikum Hamburg-Eppendorf (UKE Hamburg), Kardiologie — Hamburg, Germany (enrolling)
Acibadem City Clinic, Cardiology Department — Sofia, SOF, Bulgaria (enrolling)
Małopolskie Centrum Sercowo-Naczyniowe PAKS Oddział Intensywnej Opieki Kardiologicznej — Chrzanów, Poland (enrolling)
Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii — Dąbrowa Górnicza, Poland (enrolling)
One Day Med Sp. z o.o. Clinical Trials Department — Szczecin, Poland (enrolling)
Polsko-Amerykańskie Kliniki Serca X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach im — Tychy, Poland (enrolling)
University Clinical Centre of Serbia Department for Intensive Care in Arrhythmology — Belgrade, Serbia (enrolling)
Institute for Cardiovascular Diseases Vojvodina Department of Interventional Electrophysiology — Kamenitz, Serbia (enrolling)
University Clinical Center Kragujevac Clinic of Cardiology (Depar. Electrophysiology) — Kragujevac, Serbia (enrolling)
University Clinical Center Nis Clinic for Cardiovascular Diseases Bulevar — Niš, Serbia (enrolling)
Aleksandrovska University Hospital, Clinic of Cardiology — Sofia, SOF, Bulgaria (enrolling)
SHATC Cardiolife, Invasive Cardiology — Varna, VAR, Bulgaria (enrolling)
Medical Center Nova Clinic — Varna, VAR, Bulgaria (enrolling)
University Hospital Herlev and Gentofte Department of Cardiology — Hellerup, Denmark (enrolling)
Viborg Hospital, Department of Cardiology — Viborg, Denmark (enrolling)
Sana Kliniken Oberfranken, Klinikum Coburg Kardiologie und Innere Medizin — Coburg, Germany (enrolling)
Universitätsklinikum Frankfurt Medizinische Klinik III - Kardiologie, Angiologie, Hämostaseologie, Nephrologie — Frankfurt, Germany (enrolling)
UMHAT "Sveti Georgi" EAD, Department of Invasive Cardiology — Plovdiv, PD, Bulgaria (enrolling)
Budai Irgalmasrendi Kórház — Budapest, Hungary (enrolling)
Semmelweis Egyetem Városmajori Sziv- és Érsebészeti Klinika — Budapest, Hungary (enrolling)
Szent-Györgyi Albert Klinikai Központ, Belgyógyászati Klinika — Szeged, Hungary (enrolling)
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Rendelőintézet — Szolnok, Hungary (enrolling)
Belvárosi Egészségház, Platán Magánklinika — Zalaegerszeg, Hungary (enrolling)
Policlinico Sant'Orsola Cardiology Department — Bologna, BO, Italy (enrolling)
Arcispedale Sant'Anna, Cardiology Department — Cona, FE, Italy (enrolling)

Full record on ClinicalTrials.gov

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