Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation
Public ClinicalTrials.gov record NCT05039359. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study 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. Approximately 400 patients are expected to be enrolled in this study. Patients will be randomized 3:1 to receive FlecIH-103 at a total dose of up to 120 mg estimated total lung dose (eTLD) (n=300) or placebo inhalation solution (n=100). Randomization will be stratified by geographic region (US and ex-US) and duration of symptoms of the current AF episode (≥1 hour to ≤24 hours and \>24 hours to ≤48 hours).
Study identification
- NCT ID
- NCT05039359
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 54 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 26, 2022 (Actual)
- Primary completion
- May 22, 2023 (Actual)
- Completion
- May 22, 2023 (Actual)
- Last update posted
- Oct 30, 2023
2022 – 2023
United States locations
- U.S. sites
- 18
- U.S. states
- 9
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC Davis Medical Center | Davis | California | 95819 | — |
| Memorial Care | Long Beach | California | 90806 | — |
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | — |
| Orlando Health Heart and Vascular Institute and Orlando Regional medical Center | Orlando | Florida | 32806 | — |
| Tampa General Hospital; Center of Research Excellence | Tampa | Florida | 33606 | — |
| IU Health Ball Memorial Hospital | Muncie | Indiana | 47303 | — |
| Reid Physician Associates | Richmond | Indiana | 47374 | — |
| North Kansas City Hospital | Kansas City | Kansas | 64116 | — |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | — |
| Saint Michaels Medical Center | Newark | New Jersey | 07102 | — |
| The Valley Hospital, Inc | Ridgewood | New Jersey | 07450 | — |
| Mount Sinal Hospital | New York | New York | 10019 | — |
| Weill Cornell Medical Center | New York | New York | 10021 | — |
| University of Cincinnati College of Medicine | Cincinnati | Ohio | 45267 | — |
| The MetroHealth System | Cleveland | Ohio | 44109 | — |
| Cleveland Clinic Emergency Department | Cleveland | Ohio | 44195 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Reading Hospital | Reading | Pennsylvania | 19611 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05039359, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 30, 2023 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05039359 live on ClinicalTrials.gov.