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

Summary

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

Eligibility

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.

Conditions2

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