Clinical Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
ConditionAtrial Fibrillation (AF)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcesion Pharma
About this trial
A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- AP31969
- Placebo
Treatment groups
200 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov