RESTORE-1 FLE007

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation to Sinus Rhythm

Objective

The study is designed to evaluate the efficacy and safety of FlecIH-103 (flecainide acetate inhalation solution) compared with placebo in patients with recent-onset, symptomatic newly diagnosed or paroxysmal AF.

Study Arms

• Active Comparator: FlecIH-103 (flecainide acetate inhalation solution)
• Placebo Comparator: Vehicle-matched inhalation solution (placebo)

Eligibility

• ≥18 and ≤85 years of age
• Recent onset of symptomatic newly diagnosed or paroxysmal AF
  • Recent onset is defined as a symptom duration ≥1 and ≤48 hours at time of dosing
  • Newly diagnosed AF is AF that has not been diagnosed previously, independent of its duration
  • Paroxysmal AF is defined as recurrent AF in a patient whose previous AF episode(s) self-terminated (ie, without treatment) or terminated with intervention ≤7 days of onset.
  • A symptomatic recent-onset AF episode post cardiac ablation for paroxysmal AF would be considered eligible

NCT ID

NCT05039359