Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation
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
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Clinical Trial Information
Trial Contact: Ngo, George M.; Marquart, Vashnie; Cox, Caitlin L
Trial Phone: 3218439657 ; 321-843-1037 ; 321-841-1505
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IRB No: 22.147.07
Protocol Abbrev: RESTORE-1
Principal Investigator: Roland A. Filart, MD
Phase: Drug: Phase III
Age Group: Adult
Treatment: Drug: Placebo Vehicle-matched inhalation solution
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT05039359
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Objective
Assessment of proportion of patients whose AF converts using continuous ECG monitoring [ Time Frame: 90 minutes ]
To compare the efficacy of flecainide acetate inhalation solution and placebo for the conversion of atrial fibrillation (AF) to sinus rhythm (SR) in patients with recent-onset, symptomatic newly diagnosed or paroxysmal AF. Conversion from AF to SR will be monitored via continuous ECG recording. The efficacy of flecainide acetate solution and placebo will be compared using conversion as recorded on the ECG. -
Key Eligibility
Inclusion Criteria:
1.≥18 and ≤85 years of age
2.Recent onset of symptomatic newly diagnosed or paroxysmal AF
- a.Recent onset is defined as a symptom duration ≥1 and ≤48 hours at time of dosing
- b.Newly diagnosed AF is AF that has not been diagnosed previously, independent of its duration
- c.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.
- d.A symptomatic recent-onset AF episode post cardiac ablation for paroxysmal AF would be considered eligible
