CLINICAL TRIAL

Treatment for Atrial Fibrillation

Recruiting · 18+ · All Sexes · Long Beach, CA

Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation

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About the trial for Atrial Fibrillation

Eligible Conditions
Atrial Fibrillation · Paroxysmal Atrial Fibrillation (PAF)

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Control Group 1
Placebo
DRUG
Control Group 2
Placebo
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Atrial Fibrillation or the other condition listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
≥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
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 90 minutes
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 90 minutes.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 5 secondary outcomes in patients with Atrial Fibrillation. Measurement will happen over the course of 90 minutes post dose.

Assessing and comparing the AF related symptoms by using a questionnaire
90 MINUTES POST DOSE
To compare the effects of flecainide acetate inhalation solution and placebo on the AF-related symptoms. The AF-related symptoms will be reported by the patients in the AF-Related Symptoms Questionnaire at 90 minutes after initiation of dosing.
Assessment of proportion of patients whose AF converts using continuous ECG monitoring
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.
Time of conversion to be monitored using continuous ECGs
90 MINUTES
To compare the effects of flecainide acetate inhalation solution and placebo on the time to conversion of AF to SR. Conversion from AF to SR will be monitored via continuous ECG recording. The time of conversion as captured on the continuous ECG will be compared between flecainide acetate inhalation solution and placebo.
Assessing and comparing the hospital admissions between the active vs. placebo
90 MINUTES
To compare the effects of flecainide acetate inhalation solution and placebo on the patient hospitalizations prior to discharge as reported by the investigator in the CRF.
Assessing and comparing the AF-related interventions prior to discharge between the active vs. placebo
90 MINUTES
To compare the effects of flecainide acetate inhalation solution and placebo on the AF-related interventions as reported by the investigator in the CRF.
Assessing and comparing the time of discharge
90 MINUTES
To compare the effects of flecainide acetate inhalation solution and placebo on the time to discharge as reported by the investigator in the CRF.

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Atrial Fibrillation by sharing your contact details with the study coordinator.