The study consisted of 3 parts (Part A, Part B and Part C). Part A was an open-label, randomized, multi center design to evaluate the feasibility of administration of inhaled flecainide in two dosing regimens. Part B was an open-label, multicenter design to confirm the safety (including tolerability) and efficacy of the optimal inhaled flecainide dose determined from Part A. Part C was an open-label, multi center study with exploratory objectives to explore the feasibility of patient-led self administration of flecainide. Part C also included an exploratory sub-study to assess the feasibility of implementing a portable cardiac ultrasound (HHE) at screening in an emergent setting.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects with recent-onset symptomatic AF at presentation,
✓. With a duration at onset of symptoms from 1 hour to 48 hours,
✓. And from one of the following categories:
✓. First detected episode of paroxysmal AF
✓. Recurrent episode of paroxysmal AF
✓. Episode post-cardiac ablation for paroxysmal AF
Exclusion criteria
✕. Subject \< 18 or \> 85 years of age
✕. Hemodynamic and/or cardiac instability, with systolic blood pressure \< 100 mmHg or \> 150 mmHg, and/or ventricular heart rate \< 80 bpm or \> 150 bpm. For subjects to meet eligibility criteria, at least 2 of the 3 measurements of vital signs during screening (45, 30, and/or 15 minutes prior to dosing) must meet criteria.
✕. Current AF episode treated with Class I or Class III antiarrhythmic drugs or electrical cardioversion. Subjects whose current AF episode has been treated with flecainide are eligible if their total cumulative exposure to flecainide (including the study drug to be administered in this study) does not exceed 320 mg within a 24-hour period, per site standard of care.
What they're measuring
1
Percentage of Participants With Successful Conversion of Atrial Fibrillation to Sinus Rhythm
✕. History of acute decompensated heart failure (HF)
✕. History within 6 months prior to screening of, or present HF with a left ventricular ejection fraction (LVEF) \< 45%, and/or Class II or higher HF as defined by the New York Heart Association (NYHA), and/or medication history suggestive of HF, in the opinion of the Investigator. An echocardiogram with LVEF within 6 months of screening is required to demonstrate eligibility. If no echocardiogram is available, subject must undergo a diagnostic echocardiogram using a portable handheld ultrasound device (handheld echocardiogram; HHE) during screening to confirm eligibility.
✕. Evidence of current ongoing myocardial ischemia, such as signs (e.g., significant \[e.g., \> 2 mm\] ST segment elevation or depression on ECG, echocardiographic findings suggestive of acute myocardial infarction), symptoms (e.g., angina pectoris, atypical angina pectoris), and/or being medicated with anti-anginal medication. In addition, subjects with signs of prior myocardial infarction (such as pathological Q waves) who are also taking concomitant medications for angina pectoris should be evaluated for presence of ongoing ischemia.
✕. History of myocardial infarction (MI) within 3 months of screening
✕. Known uncorrected severe aortic or mitral stenosis