Phase 2 Atrial Fibrillation Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing and able to sign a written consent form agreeing to take part.
• People who are 18 years of age or older.
• People who have been diagnosed with a type of irregular heart rhythm called atrial fibrillation (AF), confirmed by a heart tracing (ECG), where episodes come and go or persist over time.
• People who have had at least one AF episode that stopped on its own within the 4 months before the screening visit, suggesting AF is present between 1% and 90% of the time.
• People whose AF burden (how often AF occurs) is confirmed to be between 1% and 90% during the screening period, as measured by a skin-worn heart monitor patch.
• People who agree with the trial doctor to avoid certain heart rhythm treatments outside of the trial for the entire duration of the study — this includes specific heart medications (antiarrhythmic drug classes I and III, including amiodarone), electrical or medication-based procedures to restore normal heart rhythm, and AF ablation procedures.
• People who are willing to have a small heart monitor device implanted under the skin (called a loop recorder).

Who may not be able to join:

• People who have previously had an AF ablation procedure other than a specific type called pulmonary vein isolation (PVI).
• People who have experienced any of the following within the 4 weeks before the screening visit: a heart attack, unstable chest pain (unstable angina), a stroke or mini-stroke (transient ischaemic attack), a procedure to open blocked heart arteries (PCI), heart bypass surgery (CABG), or a procedure to restore blood flow to the limbs.
• People who have a pacemaker or cardiac resynchronisation therapy device that paces the heart more than 5% of the time, or who already have an implanted loop recorder.
• People with more severe heart failure, classified as grade 3 or 4 on a standard medical scale (NYHA class III or IV).
• People whose heart pumping strength is below 40%, as measured by a heart scan (such as an echocardiogram) done within the 6 months before or during the screening visit.
• People with significant heart valve problems — including severe narrowing of the aortic valve, or severe leaking or narrowing of the mitral valve — as judged by the trial doctor.
• People whose heart's electrical interval (called QTcF) is above a certain length on their ECG: above 450 ms for males or above 470 ms for females at screening.
• People whose kidney function is below a certain level, based on a blood test result (eGFR below 60 mL/min/1.73 m²).
• People who have taken certain heart rhythm medications (antiarrhythmic drug class I or III) within 7 days before the screening visit, or who have taken amiodarone within the 3 months before the screening visit.

Important: Always verify eligibility with the trial site directly before applying.