A Randomized, Double-Blind, Placebo-Controlled Study of ATI-2042 in Patients with Paroxysmal Atrial Fibrillation and Pacemakers with Atrial Fibrillation Data Logging Capabilities

INTERVENTION: Product Code: ATI‐2042 Pharmaceutical Form: Capsule, hard Current Sponsor code: ATI‐2042 Other descriptive name: {(2S) butan‐2‐yl 2‐[3‐(4‐{2‐(diethylamino) ethoxy}‐3,5‐diiodobenzoyl) benzofuran‐2‐yl‐]acetate} Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: The trial is to investigate the efficacy of the new drug ATI‐2042 to reduce the atrial tachyarrhythmia burden in patients with paroxysmal atrial fabrilation. ATI‐2042 is designed to act like Amiodarone but with fewer side effects. ; MedDRA version: 9.1 Level: LLT Classification code 10003661 Term: Atrial fibrillation paroxysmal PRIMARY OUTCOME: Main Objective: ‐ To study the efficacy of ATI‐2042 in reducing atrial tachyarrhythmia (AT/AF) burden in patients with PAF, compared to placebo, for 12 weeks of treatment.; ‐ To study the safety and tolerability of ATI‐2042 for up to 12 weeks of treatment. Primary end point(s): Efficacy:; ‐ AT/AF burden (total time spent in AT/AF as a percentage of total observation time) over the 12‐week treatment period.; Safety:; ‐ Adverse event type and incidence.; ‐ Change from baseline in ECGs, clinical laboratory assessments, vital signs, physical examinations, chest X‐rays.; ‐ Eye examinations and pulmonary function tests. Secondary Objective: ‐ To study the effect of ATI‐2042 versus placebo on the number and duration of AT/AF episodes.; ‐ To study the effect of ATI‐2042 versus placebo on symptoms associated with PAF using a structured questionnaire. INCLUSION CRITERIA: 1. Age 18 and above. 2. Proven paroxysmal atrial fibrillation (ECG, Holter monitor, or pacemaker diagnosis obtained by the clinical site or patient’s prior medical record documenting clear evidence of a diagnosis of PAF). 3. Pacemaker with appropriate AF diagnostic and recording capabilities implanted for at least 6 weeks. Additional pacemaker requirements include: a. Dual chamber with bipolar leads. b. Able to diagnose and log atrial tachyarrhythmia events. c. Able to have atrial tachyarrhythmia treatment algorithms turned off. d. Capable of storing at least 4 weeks AT/AF data between downloads. e. Able to record and store electrograms. 4. Atrial P waves of adequate amplitude to allow accurate sensing and assessment of AT/AF episodes and no obvious indication of frequent oversensing or undersensing. 5. Able to have pacemaker atrial antitachyarrhythmia treatment algorithms turned off for the duration of the study. 6. Able to un