Clinical Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
Recruiting · NCT07267949 · Interventional (participants receive a specific treatment) · Lead sponsor: Acesion Pharma
View the official record on ClinicalTrials.gov →Interventions studied
AP31969Placebo
What this trial is about
A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
44 locations listed.
- Rijnstate Ziekenhuis, Cardiology Department - Arnhem, Netherlands
- Institute for Cardiovascular Disease "Dedinje" Department for Electrophysiology - Belgrade, Serbia
- University Clinical Centre of Serbia Department for Intensive Care in Arrhythmology - Belgrade, Serbia
- Budai Irgalmasrendi Kórház - Budapest, Hungary
- Semmelweis Egyetem Városmajori Sziv- és Érsebészeti Klinika - Budapest, Hungary
- Centrum Medyczne KERmed Cardiology Department - Bydgoszcz, Poland
- Małopolskie Centrum Sercowo-Naczyniowe PAKS Oddział Intensywnej Opieki Kardiologicznej - Chrzanów, Poland
- Sana Kliniken Oberfranken, Klinikum Coburg Kardiologie und Innere Medizin - Coburg, Germany
- Deventer Ziekenhuis, Cardiology Department - Deventer, Netherlands
- Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii - Dąbrowa Górnicza, Poland
- Universitätsklinikum Frankfurt Medizinische Klinik III - Kardiologie, Angiologie, Hämostaseologie, Nephrologie - Frankfurt, Germany
- Martini Hospital Groningen, Cardiology Department - Groningen, Netherlands
- Spaarne Gasthuis, Cardiology Department - Haarlem, Netherlands
- Universitaets Klinikum Hamburg-Eppendorf (UKE Hamburg), Kardiologie - Hamburg, Germany
- University Hospital Herlev and Gentofte Department of Cardiology - Hellerup, Denmark
- Institute for Cardiovascular Diseases Vojvodina Department of Interventional Electrophysiology - Kamenitz, Serbia
- Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach - Katowice, Poland
- Upper-Silesian Medical Center 2nd Department of Cardiology - Katowice, Poland
- University Clinical Center Kragujevac Clinic of Cardiology (Depar. Electrophysiology) - Kragujevac, Serbia
- Frisius MC Leeuwarden, Hart- en Vaatcentrum - Leeuwarden, Netherlands
- Maastricht University Medical Center, Cardiology Department - Maastricht, Netherlands
- ASST Grande Ospedale Metropolitano Niguarda Cardiology 3 - Electrophysiology "De Gasperis" Cardio Center - Milan, Italy
- University of Modena and Reggio Emilia, Policlinico di Modena, Cardiology Department - Modena, Italy
- University Clinical Center Nis Clinic for Cardiovascular Diseases Bulevar - Niš, Serbia
- Soproni Gyógyközpont Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet - Sopron, Hungary
- One Day Med Sp. z o.o. Clinical Trials Department - Szczecin, Poland
- Szent-Györgyi Albert Klinikai Központ, Belgyógyászati Klinika - Szeged, Hungary
- Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Rendelőintézet - Szolnok, Hungary
- HagaZiekenhuis, Cardiology/Electrophysiology Unit - The Hague, Netherlands
- Rivierenland Hospital, Cardiology Department - Tiel, Netherlands
- Polsko-Amerykańskie Kliniki Serca X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach im - Tychy, Poland
- Health Center Uzice Cardiology Department - Užice, Serbia
- Máxima Medisch Centrum, Cardiology Department - Veldhoven, Netherlands
- Viborg Hospital, Department of Cardiology - Viborg, Denmark
- Belvárosi Egészségház, Platán Magánklinika - Zalaegerszeg, Hungary
- Policlinico Sant'Orsola Cardiology Department - Bologna, BO, Italy
- Arcispedale Sant'Anna, Cardiology Department - Cona, FE, Italy
- UMHAT "Sveti Georgi" EAD, Department of Invasive Cardiology - Plovdiv, PD, Bulgaria
- Acibadem City Clinic, Cardiology Department - Sofia, SOF, Bulgaria
- MHAT National Cardiology Hospital EAD, Cardiology Department - Sofia, SOF, Bulgaria
- Aleksandrovska University Hospital, Clinic of Cardiology - Sofia, SOF, Bulgaria
- SHATC Cardiolife, Invasive Cardiology - Varna, VAR, Bulgaria
- Medical Center Nova Clinic - Varna, VAR, Bulgaria
- Dell'Angelo Hospital, Cardiology Department - Mestre, VE, Italy