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โ† Trials
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Clinical Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation

RecruitingPhase 2Ages 18 Years - anyAllAcesion Pharma
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 1% and โ‰ค 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 mยฒ 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.
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What it tests

  • AP31969
  • Placebo
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Where

46 sites
UMHAT "Sveti Georgi" EAD, Department of Invasive Cardiology
Plovdiv, Bulgaria
Acibadem City Clinic, Cardiology Department
Sofia, Bulgaria
MHAT National Cardiology Hospital EAD, Cardiology Department
Sofia, Bulgaria
Aleksandrovska University Hospital, Clinic of Cardiology
Sofia, Bulgaria
SHATC Cardiolife, Invasive Cardiology
Varna, Bulgaria
Medical Center Nova Clinic
Varna, Bulgaria
University Hospital Herlev and Gentofte Department of Cardiology
Hellerup, Denmark
Viborg Hospital, Department of Cardiology
Viborg, Denmark

โ€ฆand 38 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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