RecruitingPhase 2NCT07267949
Clinical Randomised Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
Sponsor
Acesion Pharma
Enrollment
200 participants
Start Date
Oct 22, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- 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 Criteria9
- 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.
Interventions
DRUGAP31969
Tablets, Oral, Twice daily.
DRUGPlacebo
Tablets, oral, Twice daily.
Locations(38)
View Full Details on ClinicalTrials.gov
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NCT07267949
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